BN83495 in Prostate Cancer
Phase 1
Completed
- Conditions
- Prostate Cancer
- Interventions
- Drug: BN83495 (Cohort 1)Drug: BN83495 (Cohort 2)Drug: BN83495 (Cohort 3)
- Registration Number
- NCT00790374
- Lead Sponsor
- Ipsen
- Brief Summary
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
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 17
Inclusion Criteria
- Confirmed and locally advanced or metastatic prostate cancer with rising prostate-specific antigen (PSA), while on androgen ablative therapy.
- Over age 18.
- Demonstrated PSA "biochemical failure".
- Adequate bone marrow and hepatic function
Exclusion Criteria
- Luteinizing Hormone-Releasing Hormone analogue treatment and treated with more than one additional second line of endocrine therapy
- Prior treatment with ketoconazole
- Prior chemotherapy for hormone refractory prostate cancer
- Pre-existing cardiac failure and/or clinically significant abnormal ECG or Echo
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort 1 BN83495 (Cohort 1) 6 patients have been enrolled, the cohort has been completed. Cohort 2 BN83495 (Cohort 2) 6 patients have been enrolled in cohort 2, the cohort has been completed. Cohort 3 BN83495 (Cohort 3) 5 patients have been enrolled in cohort 3. The cohort was closed after the 5th patient enrolled.
- Primary Outcome Measures
Name Time Method Absolute and percentage change in levels of hormones from baseline to D28/29 at 6 timepoints 28 days
- Secondary Outcome Measures
Name Time Method Pharmacokinetic assessments/Pharmacodynamic assessments Pre-determined timepoints from baseline to day 28/29 Tolerance (Physical Exam, ECOG Performance Status, Electrocardiogram, biochemistry/haematology, Urinalysis, Adverse Events, Concomitant Medications, disease progression) Each visit through day 28/29
Trial Locations
- Locations (3)
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
Johns Hopkins University Medical Center
🇺🇸Baltimore, Maryland, United States
Duke University Medical Center United States
🇺🇸Durham, North Carolina, United States