BN83495 in Prostate Cancer

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: BN83495 (Cohort 1)
* Drug: BN83495 (Cohort 2)
* Drug: BN83495 (Cohort 3)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>6 patients have been enrolled, the cohort has been completed. | Drug: BN83495 (Cohort 1)<br>* 20 mg daily BN83495 for 28 days<br>|
| Experimental: Cohort 2<br>6 patients have been enrolled in cohort 2, the cohort has been completed. | Drug: BN83495 (Cohort 2)<br>* 40 mg daily BN83495 for 28 days<br>|
| Experimental: Cohort 3<br>5 patients have been enrolled in cohort 3. The cohort was closed after the 5th patient enrolled. | Drug: BN83495 (Cohort 3)<br>* 60 mg daily BN83495 for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute and percentage change in levels of hormones from baseline to D28/29 at 6 timepoints |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | Pre-determined timepoints from baseline to day 28/29 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacodynamic profile and safety of BN83495