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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Advanced Malignant Solid Tumors

Treatments: Drug: PF-00299804

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00728468

A7471014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

16 participants in 1 patient group

Treatment arm

Experimental group

Treatment:

Drug: PF-00299804