At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 16 enrolled

Drug / intervention

PF-00299804drug

Likely dose

PF-00299804 45 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00728468

NCT00728468Phase 1Completed

Compare CT.gov

A Phase 1 Open Label, Single Arm Trial To Evaluate The Effect Of Pf-00299804 On The Pharmacokinetics Of Dextromethorphan In Patients With Advanced Malignant Solid Tumors

Pfizer·interventional·Posted Aug 5, 2008·Updated Aug 2, 2017

In Brief

A Phase 1 clinical trial evaluating PF-00299804 for Advanced Malignant Solid Tumors. Completed, enrolled 16 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAdvanced Malignant Solid Tumors

CountriesUnited States

CollaboratorsRoswell Park Cancer Institute, South Texas Accelerated Research Therapeutics (START)

Timeline

Phase 1CompletedFinished

2009201020112012201320142015201620172018201920202021202220232024202520262027

First PostedAug 2008

Enrollment StartSep 2008

Primary CompletionApr 2011

Study CompletionJul 2014

TodayJul 2026

First PostedAug 5, 2008

Enrollment StartSep 1, 2008

Primary CompletionApr 1, 2011

Study CompletionJul 1, 2014

TodayJul 2, 2026

Enrollment to primary: 2.6 yearsPosted 17.9 years ago

Interventions

PF-00299804drug

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.