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Study Of Anti-IGF-IR CP-751,871 In Patients With Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00474760
First received: May 16, 2007
Last updated: October 25, 2013
Last verified: October 2013
Results First Received: October 25, 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: Sarcoma, Ewing's
Intervention: Drug: CP-751,871

  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 3 mg/kg Figitumumab 3 milligram/kilogram (mg/kg) was supplied as a liquid solution administered as an intravenous (IV) infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 6 mg/kg Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 10 mg/kg Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 20 mg/kg Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 20 mg/kg RP2D Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for recommended Phase 2 dose [RP2D] extension cohort.
Figitumumab 20 mg/kg RP2D ACC+Sarcoma Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D adrenocortical carcinoma [ACC] and sarcoma extension cohort.
Figitumumab 20 mg/kg RP2D ESFT Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D Ewing’s sarcoma family of tumors [ESFT] extension cohort.

Participant Flow:   Overall Study
    Figitumumab 3 mg/kg     Figitumumab 6 mg/kg     Figitumumab 10 mg/kg     Figitumumab 20 mg/kg     Figitumumab 20 mg/kg RP2D     Figitumumab 20 mg/kg RP2D ACC+Sarcoma     Figitumumab 20 mg/kg RP2D ESFT  
STARTED     3     3     3     3     13     29     11  
COMPLETED     0     0     0     0     1     0     1  
NOT COMPLETED     3     3     3     3     12     29     10  
Death                 0                 0                 0                 0                 2                 0                 0  
Adverse Event                 0                 0                 0                 0                 1                 7                 0  
Laboratory abnormality                 0                 0                 0                 0                 0                 1                 0  
Withdrawal by Subject                 0                 0                 0                 1                 0                 1                 1  
Unspecified                 0                 1                 0                 0                 1                 0                 0  
Progressive disease                 3                 2                 3                 2                 8                 20                 7  
Terminated by sponsor                 0                 0                 0                 0                 0                 0                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled participants

Reporting Groups
  Description
Figitumumab 3 mg/kg Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 6 mg/kg Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 10 mg/kg Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 20 mg/kg Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
Figitumumab 20 mg/kg RP2D Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D extension cohort.
Figitumumab 20 mg/kg RP2D ACC+Sarcoma Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D ACC and sarcoma extension cohort.
Figitumumab 20 mg/kg RP2D ESFT Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
Total Total of all reporting groups

Baseline Measures
    Figitumumab 3 mg/kg     Figitumumab 6 mg/kg     Figitumumab 10 mg/kg     Figitumumab 20 mg/kg     Figitumumab 20 mg/kg RP2D     Figitumumab 20 mg/kg RP2D ACC+Sarcoma     Figitumumab 20 mg/kg RP2D ESFT     Total  
Number of Participants  
[units: participants]
  3     3     3     3     13     29     11     65  
Age, Customized  
[units: participants]
               
Less than (<) 70 years     3     3     3     3     13     28     11     64  
Equal to or greater than (>=) 70 years     0     0     0     0     0     1     0     1  
Gender  
[units: participants]
               
Female     1     2     1     0     1     13     3     21  
Male     2     1     2     3     12     16     8     44  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to 150 days after the last administration of study drug ]

2.  Secondary:   Maximum Observed Plasma Concentration (Cmax) in Cycle 1   [ Time Frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ]

3.  Secondary:   Maximum Observed Plasma Concentration (Cmax) in Cycle 4   [ Time Frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ]

4.  Secondary:   Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 1   [ Time Frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ]

5.  Secondary:   Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 4   [ Time Frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ]

6.  Secondary:   Plasma Decay Half-Life (t1/2) in Cycle 1   [ Time Frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ]

7.  Secondary:   Plasma Decay Half-Life (t1/2) in Cycle 4   [ Time Frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ]

8.  Secondary:   Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 1   [ Time Frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ]

9.  Secondary:   Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 4   [ Time Frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ]

10.  Secondary:   Systemic Clearance (CL) in Cycle 1   [ Time Frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ]

11.  Secondary:   Systemic Clearance (CL) in Cycle 4   [ Time Frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ]

12.  Secondary:   Concentration at End of Infusion (Cendinf) in Cycle 1   [ Time Frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ]

13.  Secondary:   Concentration at End of Infusion (Cendinf) in Cycle 4   [ Time Frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ]

14.  Secondary:   Volume of Distribution (Vz) in Cycle 1   [ Time Frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ]

15.  Secondary:   Volume of Distribution (Vz) in Cycle 4   [ Time Frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ]

16.  Secondary:   Volume of Distribution at Steady State (Vss) in Cycle 1   [ Time Frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ]

17.  Secondary:   Volume of Distribution at Steady State (Vss) in Cycle 4   [ Time Frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ]

18.  Secondary:   Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 1   [ Time Frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ]

19.  Secondary:   Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 4   [ Time Frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ]

20.  Secondary:   Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] in Cycle 1   [ Time Frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ]

21.  Secondary:   Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 1   [ Time Frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ]

22.  Secondary:   Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 4   [ Time Frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ]

23.  Secondary:   Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 1   [ Time Frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ]

24.  Secondary:   Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 4   [ Time Frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ]

25.  Secondary:   Human Anti-human Antibodies (HAHA) Levels   [ Time Frame: 30 minutes predose in Cycles 1 up to 61, and last scheduled follow-up visit (up to 150 days from the last dose of study drug) ]

26.  Secondary:   Number of Circulating Tumor Cells (CTCs)   [ Time Frame: 30 minutes predose in all cycles (up to 17); 1, 3, 7, and 14 days postdose in Cycle 1 for dose escalation and RP2D extension cohorts; and also 1 day postdose in Cycle 4 for RP2D extension cohort ]

27.  Secondary:   Number of Insulin-like Growth Factor 1 Receptor (IGF-1R) Positive CTCs   [ Time Frame: 30 minutes predose in all cycles (up to 17); 1, 3, 7, and 14 days postdose in Cycle 1 for dose escalation and RP2D extension cohorts; and also 1 day postdose in Cycle 4 for RP2D extension cohort ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
The study was completed and 2 participants in figitumumab 20 mg/kg RP2D ESFT group were transitioned to compassionate figitumumab treatment as investigators judged they were receiving benefit from the protocol therapy.


  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.


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 by Pfizer

Publications automatically indexed to this study:

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00474760     History of Changes
Other Study ID Numbers: A4021010
Study First Received: May 16, 2007
Results First Received: October 25, 2013
Last Updated: October 25, 2013
Health Authority: United States: Food and Drug Administration