Trials / Completed
CompletedNCT00790374
BN83495 in Prostate Cancer
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Ipsen · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BN83495 (Cohort 1) | 20 mg daily BN83495 for 28 days |
| DRUG | BN83495 (Cohort 2) | 40 mg daily BN83495 for 28 days |
| DRUG | BN83495 (Cohort 3) | 60 mg daily BN83495 for 28 days |
Timeline
- Start date
- 2009-01-01
- Primary completion
- 2010-10-01
- Completion
- 2011-02-01
- First posted
- 2008-11-13
- Last updated
- 2019-01-15
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00790374. Inclusion in this directory is not an endorsement.