Study of Dasatinib and Docetaxel in Metastatic Hormone Refractory Prostate Cancer - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00439270

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 I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Phase I/II Study of Dasatinib and Docetaxel in Metastatic Hormone Refractory Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Docetaxel Dasatinib

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 ]

Estimated Enrollment:	66
Study Start Date:	July 2007
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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

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, Illinois
Springfield Clinic
Springfield, Illinois, United States, 62703
University Of Chicago
Chicago, Illinois, United States, 60637
United States, New York
Hematology-Oncology Associates Of Rockland
Nyack, New York, United States, 10960
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
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

More Information

Additional Information:

BMS Clinical Trials Disclosure 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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA180-086
Study First Received:	February 22, 2007
Last Updated:	September 2, 2009
ClinicalTrials.gov Identifier:	NCT00439270 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Metastatic hormone refractory prostate cancer

Study placed in the following topic categories:

Docetaxel
Prostatic Diseases
Genital Neoplasms, Male
Hormone Antagonists
Dasatinib
Hormones, Hormone Substitutes, and Hormone Antagonists

Urogenital Neoplasms
Genital Diseases, Male
Protein Kinase Inhibitors
Hormones
Prostatic Neoplasms

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Urogenital Neoplasms
Genital Diseases, Male

Protein Kinase Inhibitors
Hormones
Pharmacologic Actions
Docetaxel
Neoplasms
Neoplasms by Site
Therapeutic Uses
Dasatinib
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009