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Sponsored by: |
Active Biotech Research |
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Information provided by: | Active Biotech Research |
ClinicalTrials.gov Identifier: | NCT00560482 |
To investigate ABR-215050 as a possible treatment for prostate cancer.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: ABR-215050, tasquinimod Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase II Randomized Double Blind Placebo-Controlled Study to Determine the Efficacy of ABR-215050 in Asymptomatic Patients With Metastatic Castrate-Resistant Prostate Cancer |
Estimated Enrollment: | 200 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator |
Drug: ABR-215050, tasquinimod
Gelatin capsules containing 0.25mg, 0.50mg, 1.0mg ABR-215050; 0.25mg/day taken orally once daily for 2 weeks, 0.50mg/day taken orally once daily for 2 weeks (dose-titration), and 1.0 mg/day taken once daily for 5 months (+6 months continuation)
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B: Placebo Comparator |
Drug: Placebo
Identical appearing gelatin capsules containing placebo
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For asymptomatic patients with Castrate-Resistant Prostate Cancer (CRPC), a "window of opportunity" is present. During this "window of opportunity" an intervention with little or no toxicity and the potential for extending the "symptom-free" period would be of great value to keep metastatic patients in an asymptomatic stage and thus delay the introduction of chemotherapy. The purpose of this study is to evaluate the safety and efficacy of ABR-215050 as an interventional agent for this role.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Evidence of progressive disease after castration levels of testosterone have been achieved defined by any of the following criteria:
Laboratory values as follows:
Exclusion criteria:
Contact: Goran Forsberg, Assoc. Prof. | +46 46 191154 | goran.forsberg@activebiotech.com |
Study Director: | Goran Forsberg, Assoc. Prof. | Active Biotech Research |
Principal Investigator: | Roberto Pili, MD | Johns Hopkins |
Responsible Party: | Active Biotech ( Lars M Nilsson, DVM / VP Regulatory & Quality Affairs ) |
Study ID Numbers: | 07TASQ08, EudraCT No: 2007-003470-26 |
Study First Received: | November 15, 2007 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00560482 |
Health Authority: | United States: Food and Drug Administration; Sweden: Medical Products Agency |
prostate cancer prostatic cancer castrate-resistant prostate cancer (CRPC) |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site |