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

This study has been completed.
Sponsor:
Collaborators:
Roswell Park Cancer Institute
South Texas Accelerated Research Therapeutics (START)
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00728468
First received: July 31, 2008
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Advanced Malignant Solid Tumors
Drug: PF-00299804
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Plasma pharmacokinetic parameters of dextromethorphan and dextrorphan (AUCTlast, AUCinf, Cmax, Tmax, and t1/2; oral clearance for dextromethorphan only) [ Time Frame: 17-APR-2010 ] [ Designated as safety issue: No ]
  • Plasma dextromethorphan: dextrorphan AUC ratios, and urinary dextromethorphan : dextrorphan ratios [ Time Frame: 17-APR-2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 17-APR-2010 ] [ Designated as safety issue: Yes ]
  • Best overall response as measured using the Response Evaluation Criteria in Solid Tumors (RECIST), Time to Progression (TTP), and Duration of Response (DR). [ Time Frame: 17-APR-2010 ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: September 2008
Study Completion Date: July 2014
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment arm 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.


Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728468

Locations
United States, New York
Pfizer Investigational Site
Buffalo, New York, United States, 14263
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Pfizer
Roswell Park Cancer Institute
South Texas Accelerated Research Therapeutics (START)
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00728468     History of Changes
Other Study ID Numbers: A7471014
Study First Received: July 31, 2008
Last Updated: August 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Phase 1
PF-00299804
Dextromethorphan
CYP2D6 Inhibition
Cancer Patients

Additional relevant MeSH terms:
Neoplasms
Dextromethorphan
Antitussive Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014