BN83495 in Prostate Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

November 11, 2008

Last Updated Date

November 19, 2009

Start Date ^ICMJE

January 2009

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Absolute and percentage change in levels of hormones from baseline to D28/29 at 6 timepoints [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00790374 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Tolerance (Physical Exam, ECOG Performance Status, Electrocardiogram, biochemistry/haematology, Urinalysis, Adverse Events, Concomitant Medications, disease progression) [ Time Frame: Each visit through day 28/29 ] [ Designated as safety issue: Yes ]
Pharmacokinetic assessments/Pharmacodynamic assessments [ Time Frame: Pre-determined timepoints from baseline to day 28/29 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Tolerance (Physical Exam, ECOG Performance Status, Electocardiogram, biochemistry/hematology, Urinalysis, Adverse Events, Concomitant Medications, disease progression) [ Time Frame: Each visit through D28/29 ] [ Designated as safety issue: Yes ]
Pharmacokinetic assessments/Pharmacodynamic assessments [ Time Frame: Pre-determined timepoints from baseline to D28/29 ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title ^ICMJE

BN83495 in Prostate Cancer

Official Title ^ICMJE

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

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

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Non-Randomized
Endpoint Classification:  Efficacy Study
Intervention Model:  Single Group Assignment
Masking:  Open Label
Primary Purpose:  Treatment

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Cohort 1: Experimental
1st 6 patients enrolled will be included in cohort 1. Cohort 2 activation dependent on safety of patients enrolled in cohort 1

Intervention: Drug: BN83495 (Cohort 1)
Cohort 2: Experimental
Next 6 patients will be enrolled in cohort 2 which will be activated dependent on safety of patients enrolled in cohort 1

Intervention: Drug: BN83495 (Cohort 2)
Cohort 3: Experimental
Next 6 patients will be enrolled in cohort 3 which will be activated dependent on safety of patients enrolled in cohort 2

Intervention: Drug: BN83495 (Cohort 3)

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2010

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ipsen Recruitment Enquiries

clinical.trials@ipsen.com

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00790374

Responsible Party

Eric Chetaille MD, Ipsen

Study ID Numbers ^ICMJE

X-52-58064-003

Study Sponsor ^ICMJE

Ipsen

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Eric Chetaille, MD

Ipsen

Information Provided By

Ipsen

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP