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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00728390
First received: July 31, 2008
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Carcinoma, Non-Small Cell
Neoplasm Metastasis
Drug: PF-00299804
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Targeted Combination Trial Of PF-00299804 And CP-751,871 In Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma Pharmacokinetic Parameters of PF-00299804 and CP-751,871 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Progression Free Survival (PFS) [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Best overall response (OR) defined according to RECIST guidelines. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Duration of response (DR) [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Anti-Drug Antibodies (ADA) response; [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: July 2008
Study Completion Date: January 2013
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: PF-00299804
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00728390

Locations
United States, New York
Pfizer Investigational Site
Amherst, New York, United States, 14221
Pfizer Investigational Site
Buffalo, New York, United States, 14263
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
France
Pfizer Investigational Site
Villejuif, France, 94805
Spain
Pfizer Investigational Site
Madrid, Spain, 28050
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00728390     History of Changes
Other Study ID Numbers: A7471004
Study First Received: July 31, 2008
Last Updated: October 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
advanced cancer refractory advanced non-small cell lung cancer

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Neoplasm Metastasis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on April 15, 2014