BN83495 in Prostate Cancer (STX64PC)

Ipsen

Status and phase: Completed; Phase 1

Conditions: Prostate Cancer

Treatments: Drug: BN83495 (Cohort 3); Drug: BN83495 (Cohort 2); Drug: BN83495 (Cohort 1)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00790374

X-52-58064-003

Details and patient eligibility

About

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

Full 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

Enrollment: 17 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 3 patient groups

Cohort 1

Experimental group

Description:

6 patients have been enrolled, the cohort has been completed.

Treatment:

Drug: BN83495 (Cohort 1)

Cohort 2

Experimental group

Description:

6 patients have been enrolled in cohort 2, the cohort has been completed.

Treatment:

Drug: BN83495 (Cohort 2)

Cohort 3

Experimental group

Description:

5 patients have been enrolled in cohort 3. The cohort was closed after the 5th patient enrolled.

Treatment:

Drug: BN83495 (Cohort 3)