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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Carcinoma, Non-Small Cell; Neoplasm Metastasis

Treatments: Drug: PF-00299804

Study type: Interventional

Funder types: Industry

Identifiers

NCT00728390

A7471004

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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74 participants in 1 patient group

1

Experimental group

Treatment:

Drug: PF-00299804