Study Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00729833
First received: July 30, 2008
Last updated: May 21, 2014
Last verified: May 2014
Results First Received: April 11, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Advanced Cancer
Advanced Solid Tumors
Interventions: Drug: CP-751,871
Drug: Sunitinib

  Participant Flow
  Hide Participant Flow

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 10 mg/kg + Sunitinib 25 mg CDD Figitumumab (CP-751,871) 10 milligram/kilogram (mg/kg) intravenous (IV) on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a continuous daily dosing (CDD) schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participant experienced a dose-limiting toxicity (DLT).
Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a continuous daily dosing (CDD) schedule, until disease progression or unacceptable toxicity.
Figitumumab 20 mg/kg + Sunitinib 25 mg CDD Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a continuous daily dosing (CDD) schedule, until disease progression or unacceptable toxicity.
Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1 Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of continuous daily dosing followed by 1 week off, until disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Figitumumab 10 mg/kg + Sunitinib 25 mg CDD     Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD     Figitumumab 20 mg/kg + Sunitinib 25 mg CDD     Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1  
STARTED     20     7     12     6  
COMPLETED     0     0     0     0  
NOT COMPLETED     20     7     12     6  
Death                 5                 1                 3                 5  
Study Terminated by Sponsor                 0                 0                 1                 0  
Lost to Follow-up                 1                 0                 0                 0  
Withdrawal by Subject                 3                 1                 3                 0  
Unspecified Reasons                 11                 5                 5                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Full Analysis Set: All enrolled participants who received at least 1 dose of figitumumab plus sunitinib.

Reporting Groups
  Description
Figitumumab + Sunitinib (All Combined) All participants who received at least one dose of figitumumab plus sunitinib.

Baseline Measures
    Figitumumab + Sunitinib (All Combined)  
Number of Participants  
[units: participants]
  45  
Age, Customized  
[units: participants]
 
18 to 44 years     11  
45 to 64 years     22  
Greater than or equal to (>=) 65 years     12  
Gender  
[units: participants]
 
Female     25  
Male     20  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Dose-Limiting Toxicities (DLT)   [ Time Frame: Baseline up to the end of Cycle 1 (each cycle=3 weeks) ]

2.  Secondary:   Percentage of Participants With Treatment-Emergent Adverse Events, by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for Adverse Events Grade Version 3.0   [ Time Frame: Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose) ]

3.  Secondary:   Percentage of Participants With Hematologic Laboratory Test Abnormality   [ Time Frame: Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose) ]

4.  Secondary:   Percentage of Participants With Blood Chemistry Laboratory Test Abnormality   [ Time Frame: Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose) ]

5.  Secondary:   Plasma Concentration at the End of Infusion (Cendinf) of Figitumumab   [ Time Frame: 0.5 hour predose and 1 hour post-infusion on Day 1 of Cycles 1 and 4 ]

6.  Secondary:   Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab   [ Time Frame: 0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, 15, and 22 of Cycles 1 and 4 ]

7.  Secondary:   Area Under the Curve From Time Zero to Day 22 [AUC504] of Figitumumab   [ Time Frame: 0.5 hour predose and 504 hours (Day 22) post-infusion of Cycles 1 and 4 ]

8.  Secondary:   Plasma Decay Half-Life (t1/2) of Figitumumab   [ Time Frame: 0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, and 15 of Cycles 1 and 4 ]

9.  Secondary:   Maximum Observed Plasma Concentration (Cmax) of Sunitinib   [ Time Frame: 0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1 ]

10.  Secondary:   Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib   [ Time Frame: 0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1 ]

11.  Secondary:   Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24) of Sunitinib   [ Time Frame: 0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1 ]

12.  Secondary:   Trough Plasma Concentration (Ctrough) of Sunitinib   [ Time Frame: 0.5 hour predose on Day 1 of Cycle 2 ]

13.  Secondary:   Plasma Concentration at 24 Hours Postdose (C24) of Sunitinib   [ Time Frame: 24 hours postdose on Day 15 of Cycle 1 ]

14.  Secondary:   Number of Participants With Anti-Drug Antibodies (ADA)   [ Time Frame: 0.5 hour pre-infusion on Day 1 in Cycles 1 and 2, at end of treatment, and during the last scheduled follow-up visit (5 months from the last dose of study drug) ]

15.  Secondary:   Number of Participants With Objective Response (OR)   [ Time Frame: Baseline, Day 15 of every 2 cycles until disease progression up to follow-up (approximately 28 days following the last dose of study drug) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
This study was terminated prematurely. Subsequently, ADA samples were not assayed and the pharmacokinetics of sunitinib plus its metabolite were not analyzed.


  More Information
  Hide More Information

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


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00729833     History of Changes
Other Study ID Numbers: A4021024
Study First Received: July 30, 2008
Results First Received: April 11, 2014
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration