Status:
TERMINATED
PF-00477736 Is Being Studied In Advanced Solid Tumors In Combination With Chemotherapy With Gemcitabine
Lead Sponsor:
Pfizer
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To determine the overall safety of PF-00477736 when given in combination with gemcitabine, a chemotherapy agent, in patients with advanced solid tumors and determine the maximum dose of PF-00477736 th...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00437203
Start Date
December 1 2006
End Date
April 1 2011
Last Update
April 3 2012
Active Locations (7)
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1
Pfizer Investigational Site
Los Angeles, California, United States, 90095-6984
2
Pfizer Investigational Site
Los Angeles, California, United States, 90095
3
Pfizer Investigational Site
Santa Monica, California, United States, 90403
4
Pfizer Investigational Site
Santa Monica, California, United States, 90404