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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.
 
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

Study Description
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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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2008
Actual Primary Completion Date : August 2011
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Dacomitinib

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Plasma Pharmacokinetic Parameters of PF-00299804 and CP-751,871 [ Time Frame: 12 months ]
  2. Progression Free Survival (PFS) [ Time Frame: 15 months ]
  3. Best overall response (OR) defined according to RECIST guidelines. [ Time Frame: 12 months ]
  4. Duration of response (DR) [ Time Frame: 15 months ]
  5. Anti-Drug Antibodies (ADA) response; [ Time Frame: 18 months ]
  6. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00728390


Locations
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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
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00728390    
Other Study ID Numbers: A7471004
First Posted: August 5, 2008    Key Record Dates
Last Update Posted: October 8, 2013
Last Verified: October 2013
Keywords provided by Pfizer:
advanced cancer refractory advanced non-small cell lung cancer
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes