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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2013-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Advanced Cancer Advanced Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CP-751,871 + Sunitinib

Escalating cohorts of CP-751,871 + Sunitinib

Group Type EXPERIMENTAL

CP-751,871

Intervention Type DRUG

CP-751,871 IV, every 3 weeks

Sunitinib

Intervention Type DRUG

Sunitinib - daily dosing

Interventions

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CP-751,871

CP-751,871 IV, every 3 weeks

Intervention Type DRUG

Sunitinib

Sunitinib - daily dosing

Intervention Type DRUG

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No