A Study To Test The Impact Of PF- 00299804 On How The Body Handles Dextromethorphan In Cancer Patients

Completed · Phase 1

Conditions studied: Advanced Malignant Solid Tumors

In brief

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 dextromethorphan. The purpose of this study is to test the impact of PF-00299804 on the activity of CYP2D6, and how the human body handles dextromethorphan.

Key facts

Study ID

NCT00728468

Run by

Pfizer

People needed

16

Starts

2008-09-01

Expected to finish

2014-07-01

Last updated by the study team

2017-08-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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.

Where it is running

• Roswell Park Cancer Institute — Buffalo, New York, United States
• South Texas Accelerated Research Therapeutics, LLC — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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