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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Malignant Solid Tumors

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Plasma pharmacokinetic parameters of dextromethorphan and dextrorphan (AUCTlast, AUCinf, Cmax, Tmax, and t1/2; oral clearance for dextromethorphan only)

Outcome Time Frame:

17-APR-2010

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A7471014

NCT ID:

NCT00728468

Start Date:

September 2008

Completion Date:

December 2014

Related Keywords:

  • Advanced Malignant Solid Tumors
  • Phase 1
  • PF-00299804
  • Dextromethorphan
  • CYP2D6 Inhibition
  • Cancer Patients
  • Neoplasms

Name

Location
Pfizer Investigational Site Bronx, New York  10461
Pfizer Investigational Site Houston, Texas  77030