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

Advanced Malignant Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00728468
• Other study ID #: A7471014
• Status: Completed
• Phase: Phase 1
• First received: July 31, 2008
• Last updated: August 1, 2014
• Start date: September 2008
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2014
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Advanced Malignant Solid Tumors
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Buffalo	New York
United States	Pfizer Investigational Site	San Antonio	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Pfizer	Roswell Park Cancer Institute, South Texas Accelerated Research Therapeutics (START)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma pharmacokinetic parameters of dextromethorphan and dextrorphan (AUCTlast, AUCinf, Cmax, Tmax, and t1/2; oral clearance for dextromethorphan only)		17-APR-2010	No
Primary	Plasma dextromethorphan: dextrorphan AUC ratios, and urinary dextromethorphan : dextrorphan ratios		17-APR-2010	No
Secondary	Safety in patients when study drugs are given alone or co administered will be characterized by type, frequency, severity [as graded by NCI CTCAE v.3.0], timing and relationship to study treatment of adverse events and laboratory abnormalities observed		17-APR-2010	Yes
Secondary	Best overall response as measured using the Response Evaluation Criteria in Solid Tumors (RECIST), Time to Progression (TTP), and Duration of Response (DR).		17-APR-2010	No

External Links

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