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Sponsored by: |
Ipsen |
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Information provided by: | Ipsen |
ClinicalTrials.gov Identifier: | NCT00790374 |
The purpose of the study is to evaluate the pharmacodynamic profile and safety of BN83495 in patients with prostate cancer with disease progression while on androgen ablative therapy
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: BN83495 (Cohort 1) Drug: BN83495 (Cohort 2) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | A Phase I Dose Escalating Study Evaluating the Pharmacodynamic Profile and Safety of BN83495 in Patients With Prostate Cancer With Evidence of Disease Progression While on Androgen Ablative Therapy |
Estimated Enrollment: | 12 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Cohort 1: Experimental
1st 6 patients enrolled will be included in cohort 1. Cohort 2 activation dependent on safety of patients enrolled in cohort 1
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Drug: BN83495 (Cohort 1)
20 mg daily BN83495 for 28 days
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Cohort 2: Experimental
Last 6 patients will be enrolled in cohort 2 which will be activated dependent on safety of patients enrolled in cohort 1
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Drug: BN83495 (Cohort 2)
40 mg daily BN83495 for 28 days
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Evaluate the PD profile of BN83495 after 28 days of daily oral administration in patients with locally advanced or metastatic prostate cancer on androgen ablative therapy and with rising prostatic specific antigen
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ipsen Recruitment Enquiries | clinical.trials@ipsen.com |
United States, Maryland | |
Johns Hopkins University Medical Center | Recruiting |
Baltimore, Maryland, United States, 21231 | |
United States, North Carolina | |
Duke University Medical Center United States | Recruiting |
Durham, North Carolina, United States, 27705 | |
United States, Wisconsin | |
University of Wisconsin Hospital and Clinics | Recruiting |
Madison, Wisconsin, United States, 53705 |
Study Director: | Eric Chetaille, MD | Ipsen |
Responsible Party: | Ipsen ( Eric Chetaille MD ) |
Study ID Numbers: | X-52-58064-003 |
Study First Received: | November 11, 2008 |
Last Updated: | May 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00790374 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Pharmacodynamic profile and safety of BN83495 |
Prostatic Diseases Genital Neoplasms, Male Disease Progression Urogenital Neoplasms |
Genital Diseases, Male Prostatic Neoplasms Androgens |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |