Know Cancer

or
forgot password

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
Open (Enrolling)
Male
Prostatic Neoplasms

Thank you

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 InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Midwestern Regional Medical CenterZion, Illinois  60099
University of Tennessee Cancer InstituteMemphis, Tennessee  38103
Summa Health SystemAkron, Ohio  44312
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Highlands Oncology Group, P.A.Fayetteville, Arkansas  72703
Jackson Oncology Associates, PLLCJackson, Mississippi  39202
University of WashingtonSeattle, Washington  98195
Duke University Medical CenterDurham, North Carolina  27710
University of ChicagoChicago, Illinois  60637
Tufts Medical CenterBoston, Massachusetts  02111
Compassionate Cancer Care medical Group, Inc.Fountain Valley, California  92708
VA Connecticut Healthcare SystemWest Haven, Connecticut  06516
Cancer Specialists of South Texas, PACorpus Christi, Texas  78412
Sharp Clinical Oncology ResearchSan Diego, California  92123
Connecticut Oncology GroupMiddletown, Connecticut  06457
Alaska Clinical Research CenterAnchorage, Alaska  99508
Dean Hematology and Oncology ClinicMadison, Wisconsin  53717
VA San Diego Healthcare SystemSan Diego, California  92161
Cancer Center of KansasWichita, Kansas  67214
New York Oncology Hematology, PCAlbany, New York  12208
Maine Center for Cancer MedicineScarborough, Maine  04074
The University of Texas MD Anderson Cancer CenterHouston, Texas  77030-4009
Desert Hematology Oncology Medical GroupRancho Mirage, California  92270
Suburban Hematology-Oncology Associates, PcLawrenceville, Georgia  30046
UPMC Cancer PavilionPittsburgh, Pennsylvania  15232
Southern Cancer CenterMobile, Alabama  36608
The Miriam HospitalProvidence, Rhode Island  02903
Providence Portland Med CtrPortland, Oregon  97213
Piedmont Hematology Oncology Associates, PAWinston Salem, North Carolina  27103
University Of South Alabama / Mitchell Cancer InstituteMobile, Alabama  36604
Edward Alexson, Md, Inc.Santa Ana, California  92705
Fort Wayne Medical Oncology And Hematology IncFort Wayne, Indiana  46845
North Mississippi Hematology And Oncology Associates, LtdTupelo, Mississippi  38801
Samuel S. Stratton Dept. Of Vet. Affairs Med. Ctr.Albany, New York  12208
Mid Ohio Oncology/Hematology, Inc,DbaColumbus, Ohio  43219
Regional Hematology Oncology Associates PcLanghorne, Pennsylvania  19047
Va Medical Center Pittsburgh Healthcare SystemPittsburgh, Pennsylvania  15240
Associates In Hematology & Oncology, P.C.Upland, Pennsylvania  19013
Providence Regional Cancer SystemLacey, Washington  98503