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A Study Of PF-03732010 In Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00557505
Recruitment Status : Completed
First Posted : November 14, 2007
Results First Posted : March 26, 2012
Last Update Posted : March 26, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neoplasms
Intervention Drug: PF-03732010
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PF-03732010 0.5 mg/kg Biweekly PF-03732010 1.0 mg/kg Biweekly PF-3732010 2.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Biweekly PF-03732010 8.0 mg/kg Biweekly PF-03732010 15.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Weekly PF-03732010 8.0 mg/kg Weekly PF-03732010 15.0 mg/kg Weekly
Hide Arm/Group Description PF-03732010 infusion 0.5 milligram per kilogram (mg/kg) intravenously (IV) administered over 1 hour (hr) on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days). PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days). PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
Period Title: Overall Study
Started 3 3 4 3 2 3 3 5 17
Completed 0 0 0 0 0 0 0 0 0
Not Completed 3 3 4 3 2 3 3 5 17
Reason Not Completed
Death             0             0             0             0             0             0             0             0             1
Adverse Event             0             0             1             0             0             0             1             0             0
Global deterioration of health             1             0             0             0             0             0             0             0             0
Objective progression or relapse             2             3             3             2             2             3             2             5             15
Withdrawal by Subject             0             0             0             1             0             0             0             0             1
Arm/Group Title PF-03732010 0.5 mg/kg Biweekly PF-03732010 1.0 mg/kg Biweekly PF-3732010 2.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Biweekly PF-03732010 8.0 mg/kg Biweekly PF-03732010 15.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Weekly PF-03732010 8.0 mg/kg Weekly PF-03732010 15.0 mg/kg Weekly Total
Hide Arm/Group Description PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days). PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days). PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days). Total of all reporting groups
Overall Number of Baseline Participants 3 3 4 3 2 3 3 5 17 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 4 participants 3 participants 2 participants 3 participants 3 participants 5 participants 17 participants 43 participants
18 to 44 years 0 1 0 1 0 1 0 1 1 5
45 to 64 years 1 1 3 2 2 1 1 3 13 27
Equal to or greater than 65 years 2 1 1 0 0 1 2 1 3 11
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 4 participants 3 participants 2 participants 3 participants 3 participants 5 participants 17 participants 43 participants
Female
1
  33.3%
2
  66.7%
1
  25.0%
1
  33.3%
1
  50.0%
1
  33.3%
1
  33.3%
2
  40.0%
7
  41.2%
17
  39.5%
Male
2
  66.7%
1
  33.3%
3
  75.0%
2
  66.7%
1
  50.0%
2
  66.7%
2
  66.7%
3
  60.0%
10
  58.8%
26
  60.5%
1.Primary Outcome
Title Maximum Tolerated Dose (MTD)
Hide Description [Not Specified]
Time Frame Baseline up to end of treatment (EOT) or withdrawal assessed up to Day 7 of last cycle
Hide Outcome Measure Data
Hide Analysis Population Description
MTD analysis population included all participants enrolled in the dose escalation part of the study who received at least 1 dose of study medication.
Arm/Group Title PF-03732010 0.5 mg/kg Biweekly PF-03732010 1.0 mg/kg Biweekly PF-3732010 2.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Biweekly PF-03732010 8.0 mg/kg Biweekly PF-03732010 15.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Weekly PF-03732010 8.0 mg/kg Weekly PF-03732010 15.0 mg/kg Weekly
Hide Arm/Group Description:
PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
Overall Number of Participants Analyzed 3 3 4 3 2 3 3 5 17
Measure Type: Number
Unit of Measure: mg/kg
NA [1]  NA [1]  NA [1]  NA [1]  NA [1]  NA [2]  NA [1]  NA [3]  NA [4] 
[1]
MTD was not achieved since no participant experienced dose-limiting toxicity.
[2]
MTD was not determined since schedule of administration of PF-03732010 was modified and so, the cohort was not expanded for determination of MTD.
[3]
MTD was not achieved since only 1 participant experienced dose-limiting toxicity but none experienced dose-limiting toxicity at the next higher dose.
[4]
MTD was not pursued since PF-03732010 serum concentration, attained after the dose of 15mg/Kg weekly, was above the projected efficacious trough concentration for at least 200 hrs.
2.Primary Outcome
Title Recommended Phase-2 Dose (RP2D)
Hide Description [Not Specified]
Time Frame Baseline up to EOT or withdrawal assessed up to Day 7 of last cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed, as development of the compound was terminated.
Arm/Group Title PF-03732010 0.5 mg/kg Biweekly PF-03732010 1.0 mg/kg Biweekly PF-3732010 2.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Biweekly PF-03732010 8.0 mg/kg Biweekly PF-03732010 15.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Weekly PF-03732010 8.0 mg/kg Weekly PF-03732010 15.0 mg/kg Weekly
Hide Arm/Group Description:
PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-28 Day)]
Hide Description AUC (0-28 day)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-28 day).
Time Frame 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not summarized, as development of the compound was terminated.
Arm/Group Title PF-03732010 0.5 mg/kg Biweekly PF-03732010 1.0 mg/kg Biweekly PF-3732010 2.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Biweekly PF-03732010 8.0 mg/kg Biweekly PF-03732010 15.0 mg/kg Biweekly
Hide Arm/Group Description:
PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
Overall Number of Participants Analyzed 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Time to Reach Maximum Observed Serum Concentration (Tmax)
Hide Description [Not Specified]
Time Frame 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not summarized, as development of the compound was terminated.
Arm/Group Title PF-03732010 0.5 mg/kg Biweekly PF-03732010 1.0 mg/kg Biweekly PF-3732010 2.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Biweekly PF-03732010 8.0 mg/kg Biweekly PF-03732010 15.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Weekly PF-03732010 8.0 mg/kg Weekly PF-03732010 15.0 mg/kg Weekly
Hide Arm/Group Description:
PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Minimum Observed Serum Trough Concentration (Cmin)
Hide Description [Not Specified]
Time Frame 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not summarized, as development of the compound was terminated.
Arm/Group Title PF-03732010 0.5 mg/kg Biweekly PF-03732010 1.0 mg/kg Biweekly PF-3732010 2.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Biweekly PF-03732010 8.0 mg/kg Biweekly PF-03732010 15.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Weekly PF-03732010 8.0 mg/kg Weekly PF-03732010 15.0 mg/kg Weekly
Hide Arm/Group Description:
PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Maximum Observed Serum Concentration (Cmax)
Hide Description [Not Specified]
Time Frame 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not summarized, as development of the compound was terminated.
Arm/Group Title PF-03732010 0.5 mg/kg Biweekly PF-03732010 1.0 mg/kg Biweekly PF-3732010 2.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Biweekly PF-03732010 8.0 mg/kg Biweekly PF-03732010 15.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Weekly PF-03732010 8.0 mg/kg Weekly PF-03732010 15.0 mg/kg Weekly
Hide Arm/Group Description:
PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-14 Day)]
Hide Description AUC (0-14)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-14 day).
Time Frame 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not summarized, as development of the compound was terminated.
Arm/Group Title PF-03732010 4.0 mg/kg Weekly PF-03732010 8.0 mg/kg Weekly PF-03732010 15.0 mg/kg Weekly
Hide Arm/Group Description:
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Hide Description Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
Time Frame 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not summarized, as development of the compound was terminated.
Arm/Group Title PF-03732010 0.5 mg/kg Biweekly PF-03732010 1.0 mg/kg Biweekly PF-3732010 2.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Biweekly PF-03732010 8.0 mg/kg Biweekly PF-03732010 15.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Weekly PF-03732010 8.0 mg/kg Weekly PF-03732010 15.0 mg/kg Weekly
Hide Arm/Group Description:
PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Clearance (CL)
Hide Description Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Time Frame 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not summarized, as development of the compound was terminated.
Arm/Group Title PF-03732010 0.5 mg/kg Biweekly PF-03732010 1.0 mg/kg Biweekly PF-3732010 2.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Biweekly PF-03732010 8.0 mg/kg Biweekly PF-03732010 15.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Weekly PF-03732010 8.0 mg/kg Weekly PF-03732010 15.0 mg/kg Weekly
Hide Arm/Group Description:
PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Apparent Volume of Distribution (Vd)
Hide Description Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Time Frame 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not summarized, as development of the compound was terminated.
Arm/Group Title PF-03732010 0.5 mg/kg Biweekly PF-03732010 1.0 mg/kg Biweekly PF-3732010 2.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Biweekly PF-03732010 8.0 mg/kg Biweekly PF-03732010 15.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Weekly PF-03732010 8.0 mg/kg Weekly PF-03732010 15.0 mg/kg Weekly
Hide Arm/Group Description:
PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Number of Participants With Objective Response of Complete Response or Partial Response
Hide Description Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. PR are those with at least 30 percent decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Time Frame Baseline to disease progression or 4 weeks after the first dose and then every 6 weeks up to Week 37
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed, as antitumor activity was not observed.
Arm/Group Title PF-03732010 0.5 mg/kg Biweekly PF-03732010 1.0 mg/kg Biweekly PF-3732010 2.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Biweekly PF-03732010 8.0 mg/kg Biweekly PF-03732010 15.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Weekly PF-03732010 8.0 mg/kg Weekly PF-03732010 15.0 mg/kg Weekly
Hide Arm/Group Description:
PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Other Pre-specified Outcome
Title Human Anti-Human Antibody (HAHA) Levels
Hide Description HAHA are indicators of immunogenicity to PF-03732010.
Time Frame Pre-dose on Day 1 of Cycle 2 and Day 1 of every other cycle up to Week 4, 8 and 12 after the last dose or withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed, as development of the compound was terminated.
Arm/Group Title PF-03732010 0.5 mg/kg Biweekly PF-03732010 1.0 mg/kg Biweekly PF-3732010 2.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Biweekly PF-03732010 8.0 mg/kg Biweekly PF-03732010 15.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Weekly PF-03732010 8.0 mg/kg Weekly PF-03732010 15.0 mg/kg Weekly
Hide Arm/Group Description:
PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Other Pre-specified Outcome
Title Change From Baseline in Standardized Uptake Values (SUV) of 18F-fluoro-3'-Deoxy-3'-L-fluorothymidine Positron Emission Tomography (FLT-PET)
Hide Description [Not Specified]
Time Frame Baseline, cycle 3 and after 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed, as development of the compound was terminated.
Arm/Group Title PF-03732010 0.5 mg/kg Biweekly PF-03732010 1.0 mg/kg Biweekly PF-3732010 2.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Biweekly PF-03732010 8.0 mg/kg Biweekly PF-03732010 15.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Weekly PF-03732010 8.0 mg/kg Weekly PF-03732010 15.0 mg/kg Weekly
Hide Arm/Group Description:
PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Other Pre-specified Outcome
Title Time to Disease Progression
Hide Description Time in weeks from start of study treatment to first documentation of objective disease progression or death due to disease, whichever comes first.
Time Frame Baseline to disease progression or 4 weeks after the first dose and then every 6 weeks up to Week 37
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed, as antitumor activity was not observed.
Arm/Group Title PF-03732010 0.5 mg/kg Biweekly PF-03732010 1.0 mg/kg Biweekly PF-3732010 2.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Biweekly PF-03732010 8.0 mg/kg Biweekly PF-03732010 15.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Weekly PF-03732010 8.0 mg/kg Weekly PF-03732010 15.0 mg/kg Weekly
Hide Arm/Group Description:
PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Other Pre-specified Outcome
Title Change From Baseline in Circulating Tumor Cells (CTC) Concentration in Blood
Hide Description [Not Specified]
Time Frame Pre-dose (baseline), Day 8 cycle 1, Day 1 Cycle 2 and Day 1 of every other cycle starting from cycle 3 up to EOT or withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed, as development of the compound was terminated.
Arm/Group Title PF-03732010 0.5 mg/kg Biweekly PF-03732010 1.0 mg/kg Biweekly PF-3732010 2.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Biweekly PF-03732010 8.0 mg/kg Biweekly PF-03732010 15.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Weekly PF-03732010 8.0 mg/kg Weekly PF-03732010 15.0 mg/kg Weekly
Hide Arm/Group Description:
PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Other Pre-specified Outcome
Title Change From Baseline in Leucocyte Subtypes
Hide Description [Not Specified]
Time Frame Baseline, Day 1 cycle 1, Day 1 Cycle 2, Day 1 of every other cycle starting from cycle 3 up to EOT or withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed, as development of the compound was terminated.
Arm/Group Title PF-03732010 0.5 mg/kg Biweekly PF-03732010 1.0 mg/kg Biweekly PF-3732010 2.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Biweekly PF-03732010 8.0 mg/kg Biweekly PF-03732010 15.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Weekly PF-03732010 8.0 mg/kg Weekly PF-03732010 15.0 mg/kg Weekly
Hide Arm/Group Description:
PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
17.Other Pre-specified Outcome
Title Change From Baseline in Cytokine Concentration
Hide Description [Not Specified]
Time Frame Pre-dose (baseline), 1, 6 and 24 hrs after start of infusion on Day 1 cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed, as development of the compound was terminated.
Arm/Group Title PF-03732010 0.5 mg/kg Biweekly PF-03732010 1.0 mg/kg Biweekly PF-3732010 2.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Biweekly PF-03732010 8.0 mg/kg Biweekly PF-03732010 15.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Weekly PF-03732010 8.0 mg/kg Weekly PF-03732010 15.0 mg/kg Weekly
Hide Arm/Group Description:
PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
18.Other Pre-specified Outcome
Title Change From Baseline in Tumor Proteins Related to P-cadherin Signaling and/or Tumor Proliferation or Apoptosis by Immunohistochemistry (IHC)
Hide Description [Not Specified]
Time Frame Baseline and cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed, as development of the compound was terminated.
Arm/Group Title PF-03732010 0.5 mg/kg Biweekly PF-03732010 1.0 mg/kg Biweekly PF-3732010 2.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Biweekly PF-03732010 8.0 mg/kg Biweekly PF-03732010 15.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Weekly PF-03732010 8.0 mg/kg Weekly PF-03732010 15.0 mg/kg Weekly
Hide Arm/Group Description:
PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title PF-03732010 0.5 mg/kg Biweekly PF-03732010 1.0 mg/kg Biweekly PF-3732010 2.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Biweekly PF-03732010 8.0 mg/kg Biweekly PF-03732010 15.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Weekly PF-03732010 8.0 mg/kg Weekly PF-03732010 15.0 mg/kg Weekly
Hide Arm/Group Description PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days). PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days). PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
All-Cause Mortality
PF-03732010 0.5 mg/kg Biweekly PF-03732010 1.0 mg/kg Biweekly PF-3732010 2.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Biweekly PF-03732010 8.0 mg/kg Biweekly PF-03732010 15.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Weekly PF-03732010 8.0 mg/kg Weekly PF-03732010 15.0 mg/kg Weekly
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
PF-03732010 0.5 mg/kg Biweekly PF-03732010 1.0 mg/kg Biweekly PF-3732010 2.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Biweekly PF-03732010 8.0 mg/kg Biweekly PF-03732010 15.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Weekly PF-03732010 8.0 mg/kg Weekly PF-03732010 15.0 mg/kg Weekly
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/3 (33.33%)   0/3 (0.00%)   2/4 (50.00%)   0/3 (0.00%)   0/2 (0.00%)   1/3 (33.33%)   1/3 (33.33%)   0/5 (0.00%)   4/17 (23.53%) 
Cardiac disorders                   
Pericardial effusion * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%)  0/17 (0.00%) 
General disorders                   
Asthenia * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Disease progression * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Oedema peripheral * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Infections and infestations                   
Catheter site infection * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  1/17 (5.88%) 
Lower respiratory tract infection * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%)  0/17 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                   
Tumour associated fever * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Nervous system disorders                   
Brain stem infarction * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  1/17 (5.88%) 
Renal and urinary disorders                   
Proteinuria * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Renal failure acute * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Respiratory, thoracic and mediastinal disorders                   
Dyspnoea * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  1/17 (5.88%) 
Pleural effusion * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%)  0/17 (0.00%) 
Pneumonitis * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  1/17 (5.88%) 
Pulmonary embolism * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  1/17 (5.88%) 
Vascular disorders                   
Superior vena cava syndrome * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  1/17 (5.88%) 
Thrombosis * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  1/17 (5.88%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PF-03732010 0.5 mg/kg Biweekly PF-03732010 1.0 mg/kg Biweekly PF-3732010 2.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Biweekly PF-03732010 8.0 mg/kg Biweekly PF-03732010 15.0 mg/kg Biweekly PF-03732010 4.0 mg/kg Weekly PF-03732010 8.0 mg/kg Weekly PF-03732010 15.0 mg/kg Weekly
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   3/3 (100.00%)   4/4 (100.00%)   3/3 (100.00%)   2/2 (100.00%)   3/3 (100.00%)   3/3 (100.00%)   5/5 (100.00%)   13/17 (76.47%) 
Blood and lymphatic system disorders                   
Thrombocytopenia * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Cardiac disorders                   
Palpitations * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%)  0/17 (0.00%) 
Ventricular extrasystoles * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  1/17 (5.88%) 
Ear and labyrinth disorders                   
Ear pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%)  0/17 (0.00%) 
Eye disorders                   
Diplopia * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Photophobia * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Gastrointestinal disorders                   
Abdominal discomfort * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  1/17 (5.88%) 
Abdominal distension * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  1/17 (5.88%) 
Abdominal pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  1/17 (5.88%) 
Abdominal pain upper * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Anal fissure * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Constipation * 1  1/3 (33.33%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/5 (20.00%)  2/17 (11.76%) 
Diarrhoea * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  1/3 (33.33%)  1/2 (50.00%)  1/3 (33.33%)  1/3 (33.33%)  1/5 (20.00%)  5/17 (29.41%) 
Dry mouth * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%)  0/17 (0.00%) 
Dyspepsia * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/5 (20.00%)  0/17 (0.00%) 
Epigastric discomfort * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Flatulence * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Gingival pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Inguinal hernia * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  1/17 (5.88%) 
Mouth ulceration * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Nausea * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  1/2 (50.00%)  1/3 (33.33%)  0/3 (0.00%)  1/5 (20.00%)  2/17 (11.76%) 
Proctalgia * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%)  0/17 (0.00%) 
Saliva altered * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Stomatitis * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  2/17 (11.76%) 
Tongue disorder * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Vomiting * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  1/17 (5.88%) 
General disorders                   
Asthenia * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%)  2/17 (11.76%) 
Chest pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%)  1/17 (5.88%) 
Chills * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  1/17 (5.88%) 
Fatigue * 1  1/3 (33.33%)  0/3 (0.00%)  1/4 (25.00%)  1/3 (33.33%)  2/2 (100.00%)  1/3 (33.33%)  0/3 (0.00%)  2/5 (40.00%)  3/17 (17.65%) 
Mucosal inflammation * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%)  0/17 (0.00%) 
Oedema peripheral * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%)  0/17 (0.00%) 
Pain * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  1/17 (5.88%) 
Pyrexia * 1  1/3 (33.33%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  1/17 (5.88%) 
Hepatobiliary disorders                   
Hyperbilirubinaemia * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  1/17 (5.88%) 
Infections and infestations                   
Bronchitis * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Lower respiratory tract infection * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Nasopharyngitis * 1  0/3 (0.00%)  1/3 (33.33%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Oral candidiasis * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%)  0/17 (0.00%) 
Upper respiratory tract infection * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/5 (0.00%)  1/17 (5.88%) 
Urinary tract infection * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Vaginal infection * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Injury, poisoning and procedural complications                   
Wound complication * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  1/17 (5.88%) 
Investigations                   
Blood alkaline phosphatase increased * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  1/17 (5.88%) 
Blood amylase increased * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Lipase increased * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%)  0/17 (0.00%) 
Metabolism and nutrition disorders                   
Decreased appetite * 1  1/3 (33.33%)  1/3 (33.33%)  1/4 (25.00%)  0/3 (0.00%)  1/2 (50.00%)  1/3 (33.33%)  0/3 (0.00%)  1/5 (20.00%)  2/17 (11.76%) 
Fluid retention * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%)  0/17 (0.00%) 
Gout * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Musculoskeletal and connective tissue disorders                   
Arthralgia * 1  0/3 (0.00%)  1/3 (33.33%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/5 (20.00%)  0/17 (0.00%) 
Back pain * 1  0/3 (0.00%)  1/3 (33.33%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  1/5 (20.00%)  1/17 (5.88%) 
Flank pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%)  0/17 (0.00%) 
Muscular weakness * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Musculoskeletal chest pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Musculoskeletal pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%)  0/17 (0.00%) 
Myalgia * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  1/17 (5.88%) 
Pain in extremity * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%)  0/17 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                   
Skin papilloma * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  1/17 (5.88%) 
Nervous system disorders                   
Dizziness * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/5 (0.00%)  1/17 (5.88%) 
Dysgeusia * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%)  2/17 (11.76%) 
Headache * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  2/3 (66.67%)  1/5 (20.00%)  0/17 (0.00%) 
Hypoaesthesia * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Memory impairment * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%)  0/17 (0.00%) 
Paraesthesia * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Tongue paralysis * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Psychiatric disorders                   
Anxiety * 1  0/3 (0.00%)  0/3 (0.00%)  2/4 (50.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Insomnia * 1  2/3 (66.67%)  0/3 (0.00%)  2/4 (50.00%)  0/3 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  0/5 (0.00%)  1/17 (5.88%) 
Renal and urinary disorders                   
Dysuria * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Reproductive system and breast disorders                   
Breast pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  1/17 (5.88%) 
Penile pain * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Respiratory, thoracic and mediastinal disorders                   
Cough * 1  2/3 (66.67%)  1/3 (33.33%)  1/4 (25.00%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  2/5 (40.00%)  1/17 (5.88%) 
Dysphonia * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  1/17 (5.88%) 
Dyspnoea * 1  2/3 (66.67%)  1/3 (33.33%)  2/4 (50.00%)  1/3 (33.33%)  0/2 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/5 (20.00%)  0/17 (0.00%) 
Epistaxis * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%)  0/17 (0.00%) 
Haemoptysis * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  1/17 (5.88%) 
Oropharyngeal pain * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Productive cough * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Wheezing * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  1/17 (5.88%) 
Skin and subcutaneous tissue disorders                   
Acne * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  1/17 (5.88%) 
Alopecia * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  1/3 (33.33%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Dry skin * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  1/17 (5.88%) 
Hyperhidrosis * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Hyperkeratosis * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%)  0/17 (0.00%) 
Night sweats * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%)  0/17 (0.00%) 
Pruritus * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%)  0/17 (0.00%) 
Rash * 1  1/3 (33.33%)  1/3 (33.33%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Rash macular * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
Urticaria * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  2/17 (11.76%) 
Vascular disorders                   
Haemorrhage * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%)  0/17 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
Results are not provided because development of the study drug was terminated, as neither anti-tumor activity nor pharmacodynamic modulation was observed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00557505    
Other Study ID Numbers: A9301001
First Submitted: November 12, 2007
First Posted: November 14, 2007
Results First Submitted: January 10, 2012
Results First Posted: March 26, 2012
Last Update Posted: March 26, 2012