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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 6 patients have been enrolled, the cohort has been completed. |
|
| Cohort 2 | Experimental | 6 patients have been enrolled in cohort 2, the cohort has been completed. |
|
| Cohort 3 | Experimental | 5 patients have been enrolled in cohort 3. The cohort was closed after the 5th patient enrolled. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BN83495 (Cohort 1) | Drug | 20 mg daily BN83495 for 28 days |
| |
| BN83495 (Cohort 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute and percentage change in levels of hormones from baseline to D28/29 at 6 timepoints | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance (Physical Exam, ECOG Performance Status, Electrocardiogram, biochemistry/haematology, Urinalysis, Adverse Events, Concomitant Medications, disease progression) | Each visit through day 28/29 | |
| Pharmacokinetic assessments/Pharmacodynamic assessments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University Medical Center | Baltimore | Maryland | 21231 | United States | ||
| Duke University Medical Center United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C520511 | irosustat |
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| Drug |
40 mg daily BN83495 for 28 days |
|
| BN83495 (Cohort 3) | Drug | 60 mg daily BN83495 for 28 days |
|
| Pre-determined timepoints from baseline to day 28/29 |
| Durham |
| North Carolina |
| 27705 |
| United States |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53705 | United States |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |