A Randomized Double-Blind Phase 3 Trial Comparing Docetaxel Combined With Dasatinib to Docetaxel Combined With Placebo in Castration-Resistant Prostate Cancer
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Male
Prostatic Neoplasms
Male
Prostatic Neoplasms
Trial Information
A Randomized Double-Blind Phase 3 Trial Comparing Docetaxel Combined With Dasatinib to Docetaxel Combined With Placebo in Castration-Resistant Prostate Cancer
Inclusion Criteria:
- Histologically diagnosed prostate cancer
- Evidence of metastatic disease
- Evidence of progression, by rising PSA, nodal/visceral disease, bone scan, or local
recurrence
- Serum testosterone ≤ 50 ng/dL
- Must be able to take oral medications
- Performance status 0, 1 or 2
Exclusion Criteria:
- Symptomatic brain or leptomeningeal metastases
- Clinically significant cardiovascular disease
- Pleural or pericardial effusion
- Currently active second malignancy
- Uncontrolled intercurrent illness
- Prior cytotoxic chemotherapy, with the exception of estramustine
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Overall survival
Outcome Time Frame:
Assessed at each study visit (every 3 weeks while on treatment and every 12 weeks during follow-up) to death
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA180-227
NCT ID:
NCT00744497
Start Date:
October 2008
Completion Date:
February 2013
Related Keywords:
- Prostatic Neoplasms
- Neoplasms
- Prostatic Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Midwestern Regional Medical Center | Zion, Illinois 60099 |
| University of Tennessee Cancer Institute | Memphis, Tennessee 38103 |
| Summa Health System | Akron, Ohio 44312 |
| Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
| Highlands Oncology Group, P.A. | Fayetteville, Arkansas 72703 |
| Jackson Oncology Associates, PLLC | Jackson, Mississippi 39202 |
| University of Washington | Seattle, Washington 98195 |
| Duke University Medical Center | Durham, North Carolina 27710 |
| University of Chicago | Chicago, Illinois 60637 |
| Tufts Medical Center | Boston, Massachusetts 02111 |
| Compassionate Cancer Care medical Group, Inc. | Fountain Valley, California 92708 |
| VA Connecticut Healthcare System | West Haven, Connecticut 06516 |
| Cancer Specialists of South Texas, PA | Corpus Christi, Texas 78412 |
| Sharp Clinical Oncology Research | San Diego, California 92123 |
| Connecticut Oncology Group | Middletown, Connecticut 06457 |
| Alaska Clinical Research Center | Anchorage, Alaska 99508 |
| Dean Hematology and Oncology Clinic | Madison, Wisconsin 53717 |
| VA San Diego Healthcare System | San Diego, California 92161 |
| Cancer Center of Kansas | Wichita, Kansas 67214 |
| New York Oncology Hematology, PC | Albany, New York 12208 |
| Maine Center for Cancer Medicine | Scarborough, Maine 04074 |
| The University of Texas MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| Desert Hematology Oncology Medical Group | Rancho Mirage, California 92270 |
| Suburban Hematology-Oncology Associates, Pc | Lawrenceville, Georgia 30046 |
| UPMC Cancer Pavilion | Pittsburgh, Pennsylvania 15232 |
| Southern Cancer Center | Mobile, Alabama 36608 |
| The Miriam Hospital | Providence, Rhode Island 02903 |
| Providence Portland Med Ctr | Portland, Oregon 97213 |
| Piedmont Hematology Oncology Associates, PA | Winston Salem, North Carolina 27103 |
| University Of South Alabama / Mitchell Cancer Institute | Mobile, Alabama 36604 |
| Edward Alexson, Md, Inc. | Santa Ana, California 92705 |
| Fort Wayne Medical Oncology And Hematology Inc | Fort Wayne, Indiana 46845 |
| North Mississippi Hematology And Oncology Associates, Ltd | Tupelo, Mississippi 38801 |
| Samuel S. Stratton Dept. Of Vet. Affairs Med. Ctr. | Albany, New York 12208 |
| Mid Ohio Oncology/Hematology, Inc,Dba | Columbus, Ohio 43219 |
| Regional Hematology Oncology Associates Pc | Langhorne, Pennsylvania 19047 |
| Va Medical Center Pittsburgh Healthcare System | Pittsburgh, Pennsylvania 15240 |
| Associates In Hematology & Oncology, P.C. | Upland, Pennsylvania 19013 |
| Providence Regional Cancer System | Lacey, Washington 98503 |
