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

NCT00728468 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-08-02

Study results available
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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 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.

Conditions

  • Advanced Malignant Solid Tumors

Interventions

DRUG

PF-00299804

PF-00299804: Patients take oral 45 mg PF-00299804 once daily starting on Cycle 1 Day 1 until disease progression or unacceptable toxicities occur. One cycle equals 21 days. Dextromethorphan: Patient take a single 30 mg oral dose of dextromethorphan HBr three days prior to Cycle 1 Day 1, and then on Cycle 2 Day 7.

Sponsors & Collaborators

  • Roswell Park Cancer Institute

    collaborator OTHER

  • South Texas Accelerated Research Therapeutics (START)

    collaborator UNKNOWN

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Masking
NONE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2011-04-30
Completion
2014-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00728468 on ClinicalTrials.gov