Status:
COMPLETED
A Study To Test The Impact Of PF- 00299804 On How The Body Handles Dextromethorphan In Cancer Patients
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Roswell Park Cancer Institute
South Texas Accelerated Research Therapeutics (START)
Conditions:
Advanced Malignant Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Research in test tubes suggests that may affect cytochrome P450 2D6 (CYP2D6), an important enzyme that is responsible for eliminating many drugs that cancer patients need to take, including dextrometh...
Detailed Description
To assess the effect of repeated dosing with 45 mg QD PF-00299804 on the pharmacokinetics of dextromethorphan, a CYP2D6 probe, in cancer patients with advanced malignant solid tumors.
Eligibility Criteria
Inclusion
- Patients with a histologically or cytologically confirmed advanced malignant solid tumor for which there is no currently approved treatment or which is unresponsive to currently approved therapies;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Patients with performance status 2 could be eligible upon agreement between sponsors and investigators;
- Adequate bone marrow, renal, liver and cardiac functions;
Exclusion
- History of Interstitial Lung Disease (ILD).
- Drugs with known CYP2D6 inhibitory effects
- Drugs that are highly dependent on CYP2D6 for metabolism.
- Women who are pregnant or breastfeeding.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00728468
Start Date
September 1 2008
End Date
July 1 2014
Last Update
August 2 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
2
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States, 78229