Back to resultsBN83495 in Prostate Cancer (STX64PC)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BN83495 (Cohort 1)
BN83495 (Cohort 2)
BN83495 (Cohort 3)
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Pharmacodynamic profile and safety of BN83495
Eligibility Criteria
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
Sites / Locations
- Johns Hopkins University Medical Center
- Duke University Medical Center United States
- University of Wisconsin Hospital and Clinics
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Cohort 3
Arm Description
6 patients have been enrolled, the cohort has been completed.
6 patients have been enrolled in cohort 2, the cohort has been completed.
5 patients have been enrolled in cohort 3. The cohort was closed after the 5th patient enrolled.
Outcomes
Primary Outcome Measures
Absolute and percentage change in levels of hormones from baseline to D28/29 at 6 timepoints
Secondary Outcome Measures
Tolerance (Physical Exam, ECOG Performance Status, Electrocardiogram, biochemistry/haematology, Urinalysis, Adverse Events, Concomitant Medications, disease progression)
Pharmacokinetic assessments/Pharmacodynamic assessments
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00790374
Brief Title
BN83495 in Prostate Cancer
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Pharmacodynamic profile and safety of BN83495
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
6 patients have been enrolled, the cohort has been completed.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
6 patients have been enrolled in cohort 2, the cohort has been completed.
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
5 patients have been enrolled in cohort 3. The cohort was closed after the 5th patient enrolled.
Intervention Type
Drug
Intervention Name(s)
BN83495 (Cohort 1)
Intervention Description
20 mg daily BN83495 for 28 days
Intervention Type
Drug
Intervention Name(s)
BN83495 (Cohort 2)
Intervention Description
40 mg daily BN83495 for 28 days
Intervention Type
Drug
Intervention Name(s)
BN83495 (Cohort 3)
Intervention Description
60 mg daily BN83495 for 28 days
Primary Outcome Measure Information:
Title
Absolute and percentage change in levels of hormones from baseline to D28/29 at 6 timepoints
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Tolerance (Physical Exam, ECOG Performance Status, Electrocardiogram, biochemistry/haematology, Urinalysis, Adverse Events, Concomitant Medications, disease progression)
Time Frame
Each visit through day 28/29
Title
Pharmacokinetic assessments/Pharmacodynamic assessments
Time Frame
Pre-determined timepoints from baseline to day 28/29
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Johns Hopkins University Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Duke University Medical Center United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
12. IPD Sharing Statement
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BN83495 in Prostate Cancer
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