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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 May 11, 2018

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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A Study To Test The Impact Of PF- 00299804 On How The Body Handles Dextromethorphan In Cancer Patients
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
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.
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.
Interventional
Phase 1
Masking: None (Open Label)
Advanced Malignant Solid Tumors
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.
Experimental: Treatment arm
Intervention: Drug: PF-00299804
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
July 2014
April 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00728468
A7471014
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
  • Roswell Park Cancer Institute
  • South Texas Accelerated Research Therapeutics (START)
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2017

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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