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Study Of CP-751,871 In Combination With Cisplatin And Gemcitabine In Chemotherapy-Naïve Patients With Advanced Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00560573
First received: November 15, 2007
Last updated: March 15, 2013
Last verified: March 2013
History of Changes
Results First Received: January 18, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma, Non-Small-Cell Lung
Interventions: Drug: CP-751,871
Drug: Cisplatin
Drug: Gemcitabine
Drug: Pemetrexed

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Figitumumab 6 mg/kg Figitumumab 6 milligram (mg)/kilogram (kg) was administered intravenously (IV) on Day 1 of each cycle over 2.5 hours (hr) up to 6 cycles. Gemcitabine 1250 mg/meter square (m^2) was administered IV over approximately 30 minutes (min) on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
Figitumumab 10 mg/kg Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
Figitumumab 20 mg/kg Dose Escalation Figitumumab 20 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
Figitumumab 20 mg/kg RP2D Expansion 1.0 Infusion The recommended phase 2 dose (R2PD) of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
Figitumumab 20 mg/kg Pemetrexed Expansion The RP2D of figitumumab 20 mg/kg, was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.

Participant Flow:   Overall Study
    Figitumumab 6 mg/kg     Figitumumab 10 mg/kg     Figitumumab 20 mg/kg Dose Escalation     Figitumumab 20 mg/kg RP2D Expansion 1.0 Infusion     Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion     Figitumumab 20 mg/kg Pemetrexed Expansion  
STARTED     6     3     6     10     8     13  
Treated     6     3     6     10     7     13  
COMPLETED     0     0     0     0     1     0  
NOT COMPLETED     6     3     6     10     7     13  
Death                 4                 1                 4                 5                 1                 10  
Lost to Follow-up                 0                 0                 0                 1                 1                 0  
Withdrawal by Subject                 0                 0                 0                 1                 1                 0  
Unspecified                 2                 2                 2                 3                 3                 3  
Enrolled, not treated                 0                 0                 0                 0                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
All Participants Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
 		  45  
Age  
[units: Years]
Mean ± Standard Deviation 		  59.2  ± 8.0  
Gender  
[units: Participants]
 		 
Female     9  
Male     36  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Dose-limiting Toxicities (DLT)   [ Time Frame: Start of treatment up to end of Cycle 1, Day 21 ]
  Show Outcome Measure 1

2.  Secondary:   Concentration at the End of Infusion (Cinf) for Figitumumab   [ Time Frame: Cycle 1 for dose escalation and Cycle 4 for dose expansion ]
  Show Outcome Measure 2

3.  Secondary:   Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Figitumumab   [ Time Frame: 0 (pre-dose), 1, 24, 72, 168, 336, 504 hr in Cycle 1 for dose escation and 0 (pre-dose), 1, 24, 72, 168, 336, 504 hr in Cycle 4 for expansion ]
  Show Outcome Measure 3

4.  Secondary:   Minimum Observed Plasma Trough Concentration (Cmin) for Figitumumab   [ Time Frame: 0 (pre-dose) in Cycle 5 Day 1 ]
  Show Outcome Measure 4

5.  Secondary:   Maximum Observed Plasma Concentration (Cmax) for Cisplatin   [ Time Frame: 0 (pre-dose), 1.917, 2.5, 3, 4, 5, 24 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 75 mg/m^2 and 0 (pre-dose), 0.917, 1.5, 2, 3, 4, 23 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 80 mg/m^2 ]
  Show Outcome Measure 5

6.  Secondary:   Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Cisplatin   [ Time Frame: 0 (pre-dose), 1.917, 2.5, 3, 4, 5, 24 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 75 mg/m^2 and 0 (pre-dose), 0.917, 1.5, 2, 3, 4, 23 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 80 mg/m^2 ]
  Show Outcome Measure 6

7.  Secondary:   Maximum Observed Plasma Concentration (Cmax) for Gemcitabine   [ Time Frame: 0 (pre-dose), 0.417, 1, 1.5, 2.5, 3.5 hr on Cycle 1, Day 1 and Cycle 2, Day 8 ]
  Show Outcome Measure 7

8.  Secondary:   Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Gemcitabine   [ Time Frame: 0 (pre-dose), 0.417, 1, 1.5, 2.5, 3.5 hr on Cycle 1, Day 1 and Cycle 2, Day 8 ]
  Show Outcome Measure 8

9.  Secondary:   Maximum Observed Plasma Concentration (Cmax) for Pemetrexed   [ Time Frame: 0, 0.167, 1.167, 2.167, 4.167, 6.167, 24.167 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for pemetrexed 500 mg/m^2 ]
  Show Outcome Measure 9

10.  Secondary:   Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Pemetrexed   [ Time Frame: 0, 0.167, 1.167, 2.167, 4.167, 6.167, 24.167 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for pemetrexed 500 mg/m^2 ]
  Show Outcome Measure 10

11.  Secondary:   Percentage of Participants With Objective Response or Prolonged Stabilization   [ Time Frame: Screening, from Cycle 2 onwards computerized tomography (CT) scan done within 7-10 days prior to next cycle (approximately Day 15 of each cycle), follow-up (30 days after last study treatment dose) ]
  Show Outcome Measure 11

12.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Screening, from Cycle 2 onwards CT scan done within 7-10 days prior to next cycle (approximately Day 15 of each cycle), follow-up (30 days after last study treatment dose) ]
  Show Outcome Measure 12

13.  Secondary:   Duration of Response (DR)   [ Time Frame: Screening, from Cycle 2 onwards CT scan done within 7-10 days prior to next cycle (approximately Day 15 of each cycle), follow-up (30 days after last study treatment dose) ]
  Show Outcome Measure 13

14.  Secondary:   Percentage of Participants With Blood Anti-drug Antibody (ADA) Specific for Figitumumab   [ Time Frame: 30 min prior to figitumumab infusion in Cycle 1 and Cycle 4, end of study, fourth follow up visit (approximately 150 days after last dose) ]
  Show Outcome Measure 14

15.  Secondary:   Serum Total Circulating Insulin-like Growth Factor (IGF-1) Levels   [ Time Frame: Baseline, Day 8, end of study ]
  Show Outcome Measure 15

16.  Other Pre-specified:   Maximum Tolerated Dose (MTD)   [ Time Frame: Cycle 1, up to Day 21 ]
  Show Outcome Measure 16

17.  Other Pre-specified:   Recommended Phase 2 Dose (RP2D)   [ Time Frame: Baseline to end of dose escalation, which was assessed in the last participant of the dose escalation portion of the study in Month 19 ]
  Show Outcome Measure 17


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
A total of 46 patients were enrolled in this study but only 45 of them were evaluable because 1 patient was enrolled but did not participate due to early symptomatic deterioration prior to starting treatment.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00560573     History of Changes
Other Study ID Numbers: A4021015
Study First Received: November 15, 2007
Results First Received: January 18, 2013
Last Updated: March 15, 2013
Health Authority: United States: Food and Drug Administration