Phase 1 Targeted Combination Trial Of PF-00299804 And CP-751,871 In Patients With Advanced Solid Tumors

Pfizer1 site in 1 country74 target enrollmentDecember 15, 2008

ConditionsCarcinoma, Non-Small Cell Neoplasm Metastasis

InterventionsPF-00299804

DrugsPF-00299804

Overview

Phase: Phase 1
Intervention: PF-00299804
Conditions: Carcinoma, Non-Small Cell
Sponsor: Pfizer
Enrollment: 74
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 15, 2008

End Date

January 29, 2013

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

1

Intervention: PF-00299804

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

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)