Status:
TERMINATED
Study Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors
Lead Sponsor:
Pfizer
Conditions:
Advanced Cancer
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The study is being conducted to determine the maximum tolerated dose, overall safety and tolerability profile, and pharmacokinetic profile of CP-751,871 and sunitinib when given in combination with ad...
Detailed Description
The study was closed to enrollment on 14 Jan 2011 and terminated secondary to excessive screen failure rate and for business reasons associated with Pfizer's business decision to stop development of t...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed advanced solid tumors relapsed or refractory to standard therapy or for whom no standard therapy exists.
- ECOG Performance Status of 0 or 1;
- Total IGF-1 level ≥100 ng/ml;
- ECOG Performance Status of 0 or 1
- Adequate bone marrow, renal, and hepatic function
Exclusion
- Concurrent treatment with any antitumor agents with the exception of LHRH agnosits for prostate cancer patients
- Treatment with any other investigational therapy within 4 weeks prior to study treatment
- Major surgery within 4 weeks of study treatment
- Prior treatment that may increase the risk of cardiac complications
- Ongoing cardiac dysrhythmias of NCI CTCAE Grade 2 or greater
- Significant active cardiac disease, including hypertension that cannot be controlled by medications
- Greater than three (3) prior lines of cytotoxic therapy;
- Active infection
- Prior IGF-IR targeted therapy;
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00729833
Start Date
September 1 2008
End Date
April 1 2013
Last Update
June 9 2014
Active Locations (4)
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1
Pfizer Investigational Site
Los Angeles, California, United States, 90095
2
Pfizer Investigational Site
Santa Monica, California, United States, 90404
3
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19111
4
Pfizer Investigational Site
San Antonio, Texas, United States, 78229