A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer
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Purpose
This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to treat patients with castration-resistant (hormone-refractory) prostate cancer. Additional patients will be enrolled in expanded cohorts at doses determined to be tolerable. Patients who tolerate the drug and do not progress will be allowed to continue to look for PSA response.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer Hormone Refractory Prostate Cancer |
Drug: MDV3100 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1, Open-Label, Dose-Escalation Safety and Pharmacokinetic Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer |
- Safety and Tolerability [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Pharmacokinetics, PSA response [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
MDV3100
|
Drug: MDV3100
MDV3100 daily until progression or dose-limiting toxicity
Other Name: MDV3100
|
Detailed Description:
This is a Phase 1, open-label, uncontrolled, dose-escalation study with dose-expansion at doses determined to be tolerated. Patients who tolerate the drug and do not progress will be allowed to continue treatment. The study endpoints are safety and tolerability and pharmacokinetics. PSA values will also be collected to look for PSA response.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the prostate;
- Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration);
- Progressive disease after medical or surgical castration,
Exclusion Criteria:
1. Metastases in the brain or active epidural disease. (Note: patients with treated epidural disease are allowed);
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York City, New York, United States, 10021 | |
| United States, Oregon | |
| Oregon Health and Science University | |
| Portland, Oregon, United States, 97239 | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| University of Washington | |
| Seattle, Washington, United States, 98502 | |
| Principal Investigator: | Howard Scher, MD | Memorial Sloan-Kettering Cancer Center |
More Information
No publications provided by Medivation, Inc.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Mohammad Hirmand, MD, Medivation, Inc. |
| ClinicalTrials.gov Identifier: | NCT00510718 History of Changes |
| Obsolete Identifiers: | NCT00513812 |
| Other Study ID Numbers: | S-3100-1-01 |
| Study First Received: | July 31, 2007 |
| Last Updated: | April 3, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Medivation, Inc.:
|
Prostate Cancer Hormone Refractory Castration |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013