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BN83495 in Prostate Cancer (STX64PC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00790374
Recruitment Status : Completed
First Posted : November 13, 2008
Last Update Posted : January 15, 2019
Information provided by (Responsible Party):

Brief 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

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: BN83495 (Cohort 1) Drug: BN83495 (Cohort 2) Drug: BN83495 (Cohort 3) Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Cohort 1
6 patients have been enrolled, the cohort has been completed.
Drug: BN83495 (Cohort 1)
20 mg daily BN83495 for 28 days

Experimental: Cohort 2
6 patients have been enrolled in cohort 2, the cohort has been completed.
Drug: BN83495 (Cohort 2)
40 mg daily BN83495 for 28 days

Experimental: Cohort 3
5 patients have been enrolled in cohort 3. The cohort was closed after the 5th patient enrolled.
Drug: BN83495 (Cohort 3)
60 mg daily BN83495 for 28 days

Primary Outcome Measures :
  1. Absolute and percentage change in levels of hormones from baseline to D28/29 at 6 timepoints [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Tolerance (Physical Exam, ECOG Performance Status, Electrocardiogram, biochemistry/haematology, Urinalysis, Adverse Events, Concomitant Medications, disease progression) [ Time Frame: Each visit through day 28/29 ]
  2. Pharmacokinetic assessments/Pharmacodynamic assessments [ Time Frame: Pre-determined timepoints from baseline to day 28/29 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00790374

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United States, Maryland
Johns Hopkins University Medical Center
Baltimore, Maryland, United States, 21231
United States, North Carolina
Duke University Medical Center United States
Durham, North Carolina, United States, 27705
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
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Study Director: Ipsen Medical Director Ipsen
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Responsible Party: Ipsen Identifier: NCT00790374    
Other Study ID Numbers: X-52-58064-003
First Posted: November 13, 2008    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Keywords provided by Ipsen:
Pharmacodynamic profile and safety of BN83495
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases