BN83495 in Prostate Cancer

Ipsen17 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

BN83495 (Cohort 1)DRUG

20 mg daily BN83495 for 28 days

BN83495 (Cohort 2)DRUG

40 mg daily BN83495 for 28 days

BN83495 (Cohort 3)DRUG

60 mg daily BN83495 for 28 days

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Johns Hopkins University Medical Center

Baltimore, Maryland, United States

Duke University Medical Center United States

Durham, North Carolina, United States

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Absolute and percentage change in levels of hormones from baseline to D28/29 at 6 timepoints

Time frame: 28 days

Secondary Outcomes

Tolerance (Physical Exam, ECOG Performance Status, Electrocardiogram, biochemistry/haematology, Urinalysis, Adverse Events, Concomitant Medications, disease progression)

Time frame: Each visit through day 28/29

Pharmacokinetic assessments/Pharmacodynamic assessments

Time frame: Pre-determined timepoints from baseline to day 28/29

Data from ClinicalTrials.gov

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