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

Pfizer

Status and phase

Terminated

Phase 1

Conditions

Advanced Cancer

Advanced Solid Tumors

Treatments

Drug: CP-751,871

Drug: Sunitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00729833

A4021024

Details and patient eligibility

About

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.

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

Enrollment

45 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;