A Safety And Efficacy Study Of The Combination Of Oral PF-00299804 And Intravenous CP-751,871 Given Every 3 Weeks

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-15

Study Completion Date

2013-01-29

Brief Summary

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This study will explore the combination of the oral drug PF-00299804 and intravenous CP-751,871 in patients with advanced solid tumor. Each of these drugs have been given separately to patients in prior studies, and this study is to establish the safety and efficacy of the combination.

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Detailed Description

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Conditions

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Carcinoma, Non-Small Cell Neoplasm Metastasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

PF-00299804

Intervention Type DRUG

CP-751,871 at recommended dose on Day 1 and 2 of cycle 1, then on Day 1 every 3 weeks; and PF-00299804 orally at recommended dose once daily.

Interventions

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PF-00299804

CP-751,871 at recommended dose on Day 1 and 2 of cycle 1, then on Day 1 every 3 weeks; and PF-00299804 orally at recommended dose once daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically documented advanced cancer, Eastern Cooperative Oncology Group (ECOG) 0-1;
* Platelets \> 100,000, ANC \> 1500;
* Ccr \> 60 or serum creat. \<1.5
* Non-small cell cancer cohort:
* Eastern Cooperative Oncology Group (ECOG) 0-2, prior platin, \< 4 prior chemotherapy regimen
* HgA1C \<5.7%

Exclusion Criteria

* Active Central Nervous System (CNS) metastases;
* prior IGF1-R targeted therapy
* Any history of unstable angina, myocardial infarction or symptomatic congestive heart failure.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No