BN83495 in Prostate Cancer

Prostate Cancer Clinical Trial

— STX64PC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00790374
• Other study ID #: X-52-58064-003
• Status: Completed
• Phase: Phase 1
• Start date: January 2009
• Est. completion date: February 2011

Study information

• Verified date: January 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• BN83495 (Cohort 1)
20 mg daily BN83495 for 28 days
• BN83495 (Cohort 2)
40 mg daily BN83495 for 28 days
• BN83495 (Cohort 3)
60 mg daily BN83495 for 28 days

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute and percentage change in levels of hormones from baseline to D28/29 at 6 timepoints		28 days
Secondary	Tolerance (Physical Exam, ECOG Performance Status, Electrocardiogram, biochemistry/haematology, Urinalysis, Adverse Events, Concomitant Medications, disease progression)		Each visit through day 28/29
Secondary	Pharmacokinetic assessments/Pharmacodynamic assessments		Pre-determined timepoints from baseline to day 28/29