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

Phase 1, Open Label, Sequential Cohort, Dose Escalation Study Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors

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 advanced solid tumors.

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 the figitumumab compound. Safety concerns did not contribute to the decision to terminate this clinical trial.

Inclusion Criteria:

• 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 Criteria:

• 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;