BN83495 in Prostate Cancer
STX64PC
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
1 other identifier
interventional
17
1 country
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 prostate-cancer
Started Jan 2009
Shorter than P25 for phase_1 prostate-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2008
CompletedFirst Posted
Study publicly available on registry
November 13, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedJanuary 15, 2019
January 1, 2019
1.7 years
November 11, 2008
January 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absolute and percentage change in levels of hormones from baseline to D28/29 at 6 timepoints
28 days
Secondary Outcomes (2)
Tolerance (Physical Exam, ECOG Performance Status, Electrocardiogram, biochemistry/haematology, Urinalysis, Adverse Events, Concomitant Medications, disease progression)
Each visit through day 28/29
Pharmacokinetic assessments/Pharmacodynamic assessments
Pre-determined timepoints from baseline to day 28/29
Study Arms (3)
Cohort 1
EXPERIMENTAL6 patients have been enrolled, the cohort has been completed.
Cohort 2
EXPERIMENTAL6 patients have been enrolled in cohort 2, the cohort has been completed.
Cohort 3
EXPERIMENTAL5 patients have been enrolled in cohort 3. The cohort was closed after the 5th patient enrolled.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (3)
Johns Hopkins University Medical Center
Baltimore, Maryland, 21231, United States
Duke University Medical Center United States
Durham, North Carolina, 27705, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53705, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2008
First Posted
November 13, 2008
Study Start
January 1, 2009
Primary Completion
October 1, 2010
Study Completion
February 1, 2011
Last Updated
January 15, 2019
Record last verified: 2019-01