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Phase I Study of PF-00477736 With Gemcitabine In Patients With Advanced Solid Malignancies

Phase 1
18 Years
Not Enrolling

Thank you

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:


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:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2006

Completion Date:

April 2011

Related Keywords:

  • Neoplasms
  • Advanced cancer
  • Neoplasms



Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteBronx, New York  10461