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

Last updated on November 16, 2019

FOR MORE INFORMATION
Study Location
Roswell Park Cancer Institute
Buffalo, New York, 14263 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Malignant Solid Tumors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00728468
Pfizer
Completed
A Study To Test The Impact Of PF- 00299804 On How The Body Handles Dextromethorphan In Cancer Patients

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Descriptive Information
Brief Title  ICMJE A Study To Test The Impact Of PF- 00299804 On How The Body Handles Dextromethorphan In Cancer Patients
Official Title  ICMJE 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
Brief SummaryResearch 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.
Detailed DescriptionTo 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Masking: None (Open Label)
Condition  ICMJE Advanced Malignant Solid Tumors
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Treatment arm
Intervention: Drug: PF-00299804
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 15, 2012)
16
Original Estimated Enrollment  ICMJE
 (submitted: August 4, 2008)
18
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion DateApril 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00728468
Other Study ID Numbers  ICMJE A7471014
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE
  • Roswell Park Cancer Institute
  • South Texas Accelerated Research Therapeutics (START)
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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