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Trial record 1 of 1 for:    NCT00728390
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A Safety And Efficacy Study Of The Combination Of Oral PF-00299804 And Intravenous CP-751,871 Given Every 3 Weeks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00728390
Recruitment Status : Completed
First Posted : August 5, 2008
Last Update Posted : October 8, 2013
Information provided by (Responsible Party):

Tracking Information
First Submitted Date  ICMJE July 31, 2008
First Posted Date  ICMJE August 5, 2008
Last Update Posted Date October 8, 2013
Study Start Date  ICMJE July 2008
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00728390 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2008)
  • Plasma Pharmacokinetic Parameters of PF-00299804 and CP-751,871 [ Time Frame: 12 months ]
  • Progression Free Survival (PFS) [ Time Frame: 15 months ]
  • Best overall response (OR) defined according to RECIST guidelines. [ Time Frame: 12 months ]
  • Duration of response (DR) [ Time Frame: 15 months ]
  • Anti-Drug Antibodies (ADA) response; [ Time Frame: 18 months ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Safety And Efficacy Study Of The Combination Of Oral PF-00299804 And Intravenous CP-751,871 Given Every 3 Weeks
Official Title  ICMJE Phase 1 Targeted Combination Trial Of PF-00299804 And CP-751,871 In Patients With Advanced Solid Tumors
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Carcinoma, Non-Small Cell
  • Neoplasm Metastasis
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: 1
Intervention: Drug: PF-00299804
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 24, 2013)
Original Estimated Enrollment  ICMJE
 (submitted: August 4, 2008)
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Spain,   United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00728390
Other Study ID Numbers  ICMJE A7471004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer Call Center Pfizer
PRS Account Pfizer
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP