Phase I Study of PF-00477736 With Gemcitabine In Patients With Advanced Solid Malignancies
18 Years
N/A
Both
Neoplasms
Trial Information
Phase I Study of PF-00477736 With Gemcitabine In Patients With Advanced Solid Malignancies
The study was closed to enrollment as of 17 May 2010 due to business reasons. The patient
on study continued treatment until 19 April 2011 when stopped for complete response.
Premature closure was not prompted by any safety or efficacy concerns.
Inclusion Criteria:
- Histological or cytopathological diagnosis of solid malignancy that is refractory to
standard therapy or for which no curative therapy exists.
- ECOG performance status 0 or 1.
- Adequate blood cell counts, kidney function and liver function.
Exclusion Criteria:
- Prior treatment with gemcitabine.
- Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or
leptomeningeal disease.
- NCI CTC Grade 2 or higher ARDS, non-infectious pneumonitis, or pulmonary fibrosis.
- NCI CTC Grade 2 or higher cardiovascular toxicities with the exception of NCI CTC
Grade 3 hypertension that is well controlled.
- Known human immunodeficiency virus (HIV) seropositivity.
- Concurrent treatment with anticoagulants or known coagulopathy
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum Tolerated Dose (MTD) of PF-00477736 When Administered in Combination With Gemcitabine
Outcome Time Frame:
Up to Day 21 Cycle 1
Safety Issue:
Yes
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A8211001
NCT ID:
NCT00437203
Start Date:
December 2006
Completion Date:
April 2011
Related Keywords:
- Neoplasms
- Advanced cancer
- Neoplasms
Name | Location |
|---|---|
| Pfizer Investigational Site | Blendora, California 91740 |
| Pfizer Investigational Site | Bronx, New York 10461 |
