Back to resultsA Safety And Efficacy Study Of The Combination Of Oral PF-00299804 And Intravenous CP-751,871 Given Every 3 Weeks
Primary Purpose
Carcinoma, Non-Small Cell, Neoplasm Metastasis
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
PF-00299804
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small Cell focused on measuring advanced cancer refractory advanced non-small cell lung cancer
Eligibility 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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
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.
Secondary Outcome Measures
Plasma Pharmacokinetic Parameters of PF-00299804 and CP-751,871
Progression Free Survival (PFS)
Best overall response (OR) defined according to RECIST guidelines.
Duration of response (DR)
Anti-Drug Antibodies (ADA) response;
KRAS mutation and EGFR gene amplification and mutation status in available NSCLC tumor tissue (fresh or archived) (NSCLC MTD Expansion Cohort
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00728390
Brief Title
A Safety And Efficacy Study Of The Combination Of Oral PF-00299804 And Intravenous CP-751,871 Given Every 3 Weeks
Official Title
Phase 1 Targeted Combination Trial Of PF-00299804 And CP-751,871 In Patients With Advanced Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small Cell, Neoplasm Metastasis
Keywords
advanced cancer refractory advanced non-small cell lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PF-00299804
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Plasma Pharmacokinetic Parameters of PF-00299804 and CP-751,871
Time Frame
12 months
Title
Progression Free Survival (PFS)
Time Frame
15 months
Title
Best overall response (OR) defined according to RECIST guidelines.
Time Frame
12 months
Title
Duration of response (DR)
Time Frame
15 months
Title
Anti-Drug Antibodies (ADA) response;
Time Frame
18 months
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Amherst
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Pfizer Investigational Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Pfizer Investigational Site
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28050
Country
Spain
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7471004&StudyName=A%20Safety%20And%20Efficacy%20Study%20Of%20The%20Combination%20Of%20Oral%20PF-00299804%20And%20Intravenous%20CP-751%2C871%20Given%20Every%203%20Weeks
Description
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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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