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
1 other identifier
interventional
74
3 countries
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2008
Longer than P75 for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2008
CompletedFirst Posted
Study publicly available on registry
August 5, 2008
CompletedStudy Start
First participant enrolled
December 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 9, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 29, 2013
CompletedApril 22, 2024
April 1, 2024
2.6 years
July 31, 2008
April 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
18 months
Secondary Outcomes (6)
Plasma Pharmacokinetic Parameters of PF-00299804 and CP-751,871
12 months
Progression Free Survival (PFS)
15 months
Best overall response (OR) defined according to RECIST guidelines.
12 months
Duration of response (DR)
15 months
Anti-Drug Antibodies (ADA) response;
18 months
- +1 more secondary outcomes
Study Arms (1)
1
EXPERIMENTALInterventions
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 Criteria
You may qualify if:
- 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%
You may not qualify if:
- Active Central Nervous System (CNS) metastases;
- prior IGF1-R targeted therapy
- Any history of unstable angina, myocardial infarction or symptomatic congestive heart failure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (5)
Pfizer Investigational Site
Amherst, New York, 14221, United States
Pfizer Investigational Site
Buffalo, New York, 14263, United States
Pfizer Investigational Site
San Antonio, Texas, 78229, United States
Pfizer Investigational Site
Villejuif, 94805, France
Pfizer Investigational Site
Madrid, 28050, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2008
First Posted
August 5, 2008
Study Start
December 15, 2008
Primary Completion
August 9, 2011
Study Completion
January 29, 2013
Last Updated
April 22, 2024
Record last verified: 2024-04