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
18 Years
N/A
Both
Advanced Malignant Solid Tumors
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 |
