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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

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ClinicalTrials.gov Identifier: NCT00728390
Recruitment Status : Completed
First Posted : August 5, 2008
Last Update Posted : October 8, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

July 31, 2008
August 5, 2008
October 8, 2013
July 2008
August 2011   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00728390 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Safety And Efficacy Study Of The Combination Of Oral PF-00299804 And Intravenous CP-751,871 Given Every 3 Weeks
Phase 1 Targeted Combination Trial Of PF-00299804 And CP-751,871 In Patients With Advanced Solid Tumors
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Carcinoma, Non-Small Cell
  • Neoplasm Metastasis
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.
Experimental: 1
Intervention: Drug: PF-00299804
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
45
January 2013
August 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France,   Spain,   United States
 
 
NCT00728390
A7471004
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2013

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