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PF-00477736 Is Being Studied In Advanced Solid Tumors In Combination With Chemotherapy With Gemcitabine

Last updated on May 11, 2018

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Study Location
Pfizer Investigational Site
Los Angeles, California, 90095-6984 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00437203
Pfizer
Terminated
PF-00477736 Is Being Studied In Advanced Solid Tumors In Combination With Chemotherapy With Gemcitabine

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PF-00477736 Is Being Studied In Advanced Solid Tumors In Combination With Chemotherapy With Gemcitabine
Phase I Study of PF-00477736 With Gemcitabine In Patients With Advanced Solid Malignancies
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 that can be safely given in combination with gemcitabine. This is the first study of PF-00477736 in humans.
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.
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Neoplasms
  • Drug: PF-00477736
    • Escalating doses of PF-00477736 will be administered intravenously on Days 2 and 9 and gemcitabine will be administered intravenously on Days 1 and 8 of a 21-day cycle (doses to be evaluated range from 750 to 1250 mg/m2 in three separated cohorts).
    • If a patient is administered Cycle 0 - only PF-0047736 will be administered intravenously on Days 1 and 8 of a 21-day cycle for patients who have a 3-hour infusion and Days 1 and 8 of a 14-day cycle for patients who have a 24-hour infusion.
  • Drug: gemcitabine
    gemcitabine will be administered intravenously on Days 1 and 8 of a 21-day cycle (doses to be evaluated range from 750 to 1250 mg/m2 in three separated cohorts).
Experimental: 1
Interventions:
  • Drug: PF-00477736
  • Drug: gemcitabine
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
43
April 2011
April 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   United States
 
 
NCT00437203
A8211001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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