BN83495 in Prostate Cancer (STX64PC)

January 11, 2019 updated by: Ipsen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Johns Hopkins University Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin Hospital and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

February 1, 2011

Study Registration Dates

First Submitted

November 11, 2008

First Submitted That Met QC Criteria

November 12, 2008

First Posted (ESTIMATE)

November 13, 2008

Study Record Updates

Last Update Posted (ACTUAL)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 11, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X-52-58064-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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