Trial of Dasatinib (Sprycel®) in Subjects With Hormone-refractory Prostate Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by University of California, Irvine.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of California, Irvine
Collaborator:
Bristol-Myers Squibb
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00570700
First received: December 6, 2007
Last updated: May 12, 2010
Last verified: May 2010
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Purpose
The purpose of this research study is to find out if a new anti-cancer drug, dasatinib (Sprycel®), previously approved for treatment of some forms of leukemia, will be safe and helpful in treating patients with hormone-refractory prostate cancer.
This is a research study because the study drug, dasatinib (Sprycel®), has not been evaluated for safety or effectiveness in patients with hormone-refractory prostate cancer. The drug is approved by the Food and Drug Administration for treatment of some forms of leukemia; thus, dasatinib (Sprycel®) is not an investigational drug. It has been given safely to hundreds of patients already. However its safety and usefulness in this study population (prostate cancer) is unknown.
Subjects who agree to participate will take 150mg (3 pills) of dasatinib (Sprycel®) daily by mouth for as long as the drug benefits them. During this time, the subject will periodically return to the office for blood/urine tests, X-rays, imaging scans, and/or to complete questionnaires.
| Condition | Intervention | Phase |
|---|---|---|
|
Hormone-Refractory Prostate Cancer |
Drug: Dasatinib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | BMS CA180-097: A Phase II Trial of Dasatinib (Sprycel®) in Subjects With Hormone-refractory Prostate Cancer, Previously Treated With Chemotherapy |
Resource links provided by NLM:
Further study details as provided by University of California, Irvine:
Primary Outcome Measures:
- Define the frequency of "positive effects" from dasatinib treatment of subjects with hormone-refractory prostate cancer, who have had prior chemotherapy. [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 41 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Dasatinib
150mg (3 pills) daily for as long as the drug benefits
Other Name: Sprycel®
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient has prostate cancer that is getting worse after treatment with hormone-blocking therapies such as orchiectomy (removal of a testicle), prostate cancer treatment pills (Casodex, Eulexin, Nilandrone, bicalutamide, flutamide, nilutamide), or hormone shots (Lupron, Eligard, leuprolide, Zoladex, gosserelin)
- 18 years of age or older
- At least one dose/cycle of chemotherapy drugs (docetaxel, Taxotere, estramustine, Emcyt, mitoxantrone, Novantrone, etc.)
- Normal kidney and liver function, and normal blood counts
- Able to swallow pills
- Use a valid form of birth control while taking the study drug and for at least 4 weeks afterwards
Exclusion Criteria:
- Chemotherapy in the last 4 weeks
- Radiation therapy in the past six weeks
- Quadramet (samarium 153) therapy (a drug used to relieve bone pain) in the past two months, or Metastron (strontium-89), another drug used to relieve bone pain, ever
- Treatment with any tyrosine kinase inhibitor (a type of therapy that controls cancerous cell growth). Investigational chemotherapy drugs must have been taken at least six weeks ago, and investigational vaccines at least six months ago.
- Any other cancer, other than prostate cancer, that required chemotherapy, hormone therapy, or radiation therapy in the past five years
- Uncontrolled heart failure, heart attack, or chest pains within the previous six months
- History of unstable heart rhythms
- Medicines known to cause heart rhythm disturbances, including quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, erythromycin, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, and lidoflazine. There are restrictions or limitations to use of other medicines as well, such as anticoagulants (drugs that stop blood from clotting), intravenous bisphosphonates (bone-hardening medicines), and anti-acid agents such as omeprazole, lansoprazole, cimetidine, ranitidine, and other H2 blockers/proton pump inhibitors. Patients may not take St. John's Wort while on study.
- History of abnormal bleeding, such as hemophilia, von Willebrand's disease, or are using full-dose anticoagulants (substances that stop the blood from clotting). Patients may not have had any stomach or intestinal bleeding in the past three months.
- Untreated brain cancer, or untreated prostate cancer causing spinal cord compression
- May not drink Grapefruit Juice during this study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570700
Locations
| United States, California | |
| Chao Family Comprehensive Cancer Center | |
| Orange, California, United States, 92868 | |
Sponsors and Collaborators
University of California, Irvine
Bristol-Myers Squibb
Investigators
| Principal Investigator: | Michael B Lilly, MD, FACP | Chao Family Comprehensive Cancer Center |
More Information
No publications provided
| Responsible Party: | Michael Lilly, MD, University of California, Irvine Medical Center |
| ClinicalTrials.gov Identifier: | NCT00570700 History of Changes |
| Other Study ID Numbers: | UCI 06-60, HS#2007-5564, BMS CA180-097 |
| Study First Received: | December 6, 2007 |
| Last Updated: | May 12, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Irvine:
|
prostate |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male |
Prostatic Diseases Dasatinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013