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Study of Dasatinib and Docetaxel in Metastatic Hormone Refractory Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00439270
First received: February 22, 2007
Last updated: March 28, 2013
Last verified: December 2012
History of Changes
  Purpose

The purpose of this study is to find the recommended doses of dasatinib and docetaxel given in combination to men with metastatic hormone refractory prostate cancer. Pharmacokinetic interactions between the two drugs will be assessed.


Condition Intervention Phase
Metastatic Prostate Cancer
 Drug: Dasatinib + Docetaxel
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of Dasatinib and Docetaxel in Metastatic Hormone Refractory Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Continuous safety assessment [ Time Frame: throughout treatment ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic data approximately [ Time Frame: at day 1, 14, and 22 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess safety and tolerability of combination [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
  • Estimate efficacy (prostate-specific antigen [PSA], objective tumor response, progression free survival, bone scan changes) [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: July 2007
Study Completion Date: January 2013
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Dasatinib + Docetaxel
Tablets + Infusion, Oral + Infusion, 50-150 mg + 60-75 mg/m2, once daily + every 21 days, treatment may continue until disease progression
Other Names:
  • Sprycel
  • BMS-354825

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males, 18 and older
  • Confirmed adenocarcinoma of the prostate
  • Radiographic evidence of progressive metastatic disease with serum PSA ≥ 5
  • Serum testosterone ≤ 50

Exclusion Criteria:

  • Known brain metastases
  • Currently active secondary malignancy
  • No more than one prior chemotherapy for prostate cancer, as long as docetaxel resistance or intolerance was not shown
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00439270

Locations
United States, Texas
The University Of Texas Md Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00439270     History of Changes
Other Study ID Numbers: CA180-086
Study First Received: February 22, 2007
Last Updated: March 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Metastatic hormone refractory prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Docetaxel
 Dasatinib
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013