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

Phase 1

Completed

• Conditions: Neoplasm Metastasis; Carcinoma, Non-Small Cell
• Interventions: Drug: PF-00299804

• Registration Number: NCT00728390
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-31
• Study First Submitted QC: 2008-08-04
• Study First Posted: 2008-08-05
• Study Start: 2008-12-15
• Primary Completion: 2011-08-09
• Study Completion: 2013-01-29
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	PF-00299804	-

Primary Outcome Measures

Name	Time	Method
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.	18 months

Secondary Outcome Measures

Name	Time	Method
Anti-Drug Antibodies (ADA) response;	18 months
Best overall response (OR) defined according to RECIST guidelines.	12 months
Plasma Pharmacokinetic Parameters of PF-00299804 and CP-751,871	12 months
KRAS mutation and EGFR gene amplification and mutation status in available NSCLC tumor tissue (fresh or archived) (NSCLC MTD Expansion Cohort	12 months
Progression Free Survival (PFS)	15 months
Duration of response (DR)	15 months

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇪🇸 Madrid, Spain