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

Pfizer74 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Non-Small Cell Neoplasm Metastasis

Interventions

PF-00299804DRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

Pfizer Investigational Site

Amherst, New York, United States

Pfizer Investigational Site

Buffalo, New York, United States

Pfizer Investigational Site

San Antonio, Texas, United States

Pfizer Investigational Site

Villejuif, France

Outcomes

Primary Outcomes

Overall safety profile characterized by type, frequency, severity (as graded using NCI CTC AE v. 3.0), timing, seriousness and relationship to trial treatment of adverse events and laboratory abnormalities.

Time frame: 18 months

Secondary Outcomes

Plasma Pharmacokinetic Parameters of PF-00299804 and CP-751,871

Time frame: 12 months

Progression Free Survival (PFS)

Time frame: 15 months

Best overall response (OR) defined according to RECIST guidelines.

Time frame: 12 months

Duration of response (DR)

Time frame: 15 months

Anti-Drug Antibodies (ADA) response;

Time frame: 18 months

KRAS mutation and EGFR gene amplification and mutation status in available NSCLC tumor tissue (fresh or archived) (NSCLC MTD Expansion Cohort

Time frame: 12 months

Data from ClinicalTrials.gov

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