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Sponsored by: |
PRAECIS Pharmaceuticals Inc. |
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Information provided by: | PRAECIS Pharmaceuticals Inc. |
ClinicalTrials.gov Identifier: | NCT00100243 |
This is a Phase 2, open-label study in subjects with androgen-independent prostate cancer who have progressed following treatment with an LHRH agonist. Up to 22 subjects will be enrolled. Enrollment will be monitored to ensure that not all subjects are enrolled based on rising prostate specific antigen (PSA) criterion only.
Subjects will be treated with abarelix (Plenaxis) 100 mg intramuscularly (IM) every 2 weeks for 12 weeks (total dose of 600 mg).
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: Plenaxis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase 2 Study of Abarelix in Androgen-Independent Prostate Cancer Progressing After Agonist Therapy |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histologically or cytologically confirmed prostate cancer that has progressed within 60 days of the start of screening despite castrate levels of testosterone from treatment with an LHRH agonist. Progression will be defined as one or more of the following: *A rising PSA, defined as at least two consecutive rises in PSA over a reference value (PSA #1). The first rising PSA (PSA #2) must be taken at least one week after PSA #1. A third PSA (PSA #3) is required to be greater than PSA #2; if not, a fourth PSA (PSA #4) is required to be greater than PSA #2, OR
Exclusion Criteria:
A subject is ineligible to participate in the study if he meets any of the following criteria:
Prior treatment for prostate cancer with:
United States, California | |
San Diego Center for Urology | |
La Mesa, California, United States, 91942 | |
United States, Florida | |
Southwest Florida Urological Associates | |
Fort Myers, Florida, United States, 33907 | |
Panama City Urological Center | |
Panama City, Florida, United States, 32405 | |
United States, Ohio | |
Columbus Urology Research, LLC | |
Columbus, Ohio, United States, 43214 | |
United States, Oregon | |
Oregon Health & Science University | |
Portland, Oregon, United States, 97201-3098 | |
United States, Pennsylvania | |
Urological Associates of Lancaster | |
Lancaster, Pennsylvania, United States, 17604-3200 | |
United States, South Carolina | |
Carolina Urologic Research Center | |
Myrtle Beach, South Carolina, United States, 29572 |
Study Director: | Marc Garnick, MD | PRAECIS PHARMACEUTICALS |
Study ID Numbers: | 149-04-01 |
Study First Received: | December 27, 2004 |
Last Updated: | September 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00100243 |
Health Authority: | United States: Food and Drug Administration |
androgen-independent prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site |