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Clinical Trials/NCT00728390
NCT00728390CompletedPhase 1

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

Pfizer1 site in 1 country74 target enrollmentStarted: December 15, 2008Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
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.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Experimental

Intervention: PF-00299804 (Drug)

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)

Investigators

Sponsor
Pfizer
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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