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Study Of CP-751,871 In Patients With Ewing's Sarcoma Family Of Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00560235
First received: November 15, 2007
Last updated: January 14, 2014
Last verified: January 2014
Results First Received: October 24, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Ewing's Sarcoma Family of Tumors
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
Participants were recruited separately for Phase 1 and Phase 2. A total of 138 participants were assigned to received study treatment (31 participants for Phase 1 and 107 participants for Phase 2).

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 Dose Escalation (Phase 1) Figitumumab 20 milligrams per kilogram (mg/kg) intravenous (IV) administered every 4 weeks (1 cycle). If no dose-limiting toxicity (DLT) was identified in the 20-mg/kg cohort, dose escalation proceeded to 30-mg/kg. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
Figitumumab Dose Extension (Phase 1B) Figitumumab 20 mg/kg or 30 mg/kg IV administered every 4 weeks (1 cycle). Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
Figitumumab 30 mg/kg (Phase 2) Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.

Participant Flow for 3 periods

Period 1:   Phase 1
    Figitumumab Dose Escalation (Phase 1)     Figitumumab Dose Extension (Phase 1B)     Figitumumab 30 mg/kg (Phase 2)  
STARTED     10     0     0  
COMPLETED     2     0     0  
NOT COMPLETED     8     0     0  
Discontinued                 8                 0                 0  

Period 2:   Phase 1B
    Figitumumab Dose Escalation (Phase 1)     Figitumumab Dose Extension (Phase 1B)     Figitumumab 30 mg/kg (Phase 2)  
STARTED     0     21     0  
COMPLETED     0     2     0  
NOT COMPLETED     0     19     0  
Discontinued                 0                 19                 0  

Period 3:   Phase 2
    Figitumumab Dose Escalation (Phase 1)     Figitumumab Dose Extension (Phase 1B)     Figitumumab 30 mg/kg (Phase 2)  
STARTED     0     0     107  
COMPLETED     0     0     10  
NOT COMPLETED     0     0     97  
Discontinued                 0                 0                 96  
Ongoing at Date of Cut-Off                 0                 0                 1  



  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.
No text entered.

Reporting Groups
  Description
Figitumumab Dose Escalation (Phase 1) Figitumumab 20 milligrams per kilogram (mg/kg) intravenous (IV) administered every 4 weeks (1 cycle). If no dose-limiting toxicity (DLT) was identified in the 20-mg/kg cohort, dose escalation proceeded to 30-mg/kg. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
Figitumumab Dose Extension (Phase 1B) Figitumumab 20 mg/kg or 30 mg/kg IV administered every 4 weeks (1 cycle). Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
Figitumumab 30 mg/kg (Phase 2) Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
Total Total of all reporting groups

Baseline Measures
    Figitumumab Dose Escalation (Phase 1)     Figitumumab Dose Extension (Phase 1B)     Figitumumab 30 mg/kg (Phase 2)     Total  
Number of Participants  
[units: participants]
  10     21     107     138  
Age, Customized  
[units: participants]
       
10 to <13 years     2     3     17     22  
13 to <=18 years     8     18     30     56  
18 to <30 years     0     0     43     43  
30 to <41 years     0     0     10     10  
>=41 years     0     0     7     7  
Gender  
[units: participants]
       
Female     4     7     40     51  
Male     6     14     67     87  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Response Rate (ORR)   [ Time Frame: Baseline and every cycle (4 weeks), for up to 6 cycles ]

2.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Baseline and every cycle (4 weeks), until progression or death ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: Baseline and every 2 cycles (8 weeks), until death or up to 6 cycles after date of enrollment ]

4.  Secondary:   Maximum Observed Plasma Concentration (Cmax)   [ Time Frame: Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1 ]

5.  Secondary:   Minimum Observed Plasma Trough Concentration (Cmin)   [ Time Frame: Cycle 6: predose on Day 1 ]

6.  Secondary:   Plasma Concentration at End of Infusion (Cendinf)   [ Time Frame: Cycle 1 Day 2 and Cycle 5 Day 1 ]

7.  Secondary:   Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)   [ Time Frame: Cycle 5: 1 hour post-infusion on Day 1 ]

8.  Secondary:   Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)   [ Time Frame: Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1 ]

9.  Secondary:   Number of Participants With Positive Anti-Drug Antibody (ADA) Titer   [ Time Frame: Cycle 4 (predose on Day 1), 28 days after last dose (End-of-Treatment), and follow-up (approximately 150 days after last dose) ]


  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
No text entered.


  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: NCT00560235     History of Changes
Other Study ID Numbers: A4021020
Study First Received: November 15, 2007
Results First Received: October 24, 2013
Last Updated: January 14, 2014
Health Authority: United States: Food and Drug Administration