BN83495 in Prostate Cancer - Full Text View

Sponsor:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00790374

Purpose

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	Intervention	Phase
Prostate Cancer	Drug: BN83495 (Cohort 1) Drug: BN83495 (Cohort 2) Drug: BN83495 (Cohort 3)	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	17
Study Start Date:	January 2009
Study Completion Date:	February 2011
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790374

Locations

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

Ipsen

Investigators

Study Director:

Eric Chetaille, MD

Ipsen

More Information

No publications provided

Responsible Party:	Eric Chetaille MD, Ipsen
ClinicalTrials.gov Identifier:	NCT00790374 History of Changes
Other Study ID Numbers:	X-52-58064-003
Study First Received:	November 11, 2008
Last Updated:	February 28, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ipsen:

Pharmacodynamic profile and safety of BN83495

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 24, 2012