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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


Phase 1
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Absolute and percentage change in levels of hormones from baseline to D28/29 at 6 timepoints

Outcome Time Frame:

28 days

Safety Issue:

No

Principal Investigator

Eric Chetaille, MD

Investigator Role:

Study Director

Investigator Affiliation:

Ipsen

Authority:

United States: Food and Drug Administration

Study ID:

X-52-58064-003

NCT ID:

NCT00790374

Start Date:

January 2009

Completion Date:

February 2011

Related Keywords:

  • Prostate Cancer
  • Pharmacodynamic profile and safety of BN83495
  • Prostatic Neoplasms

Name

Location

University of Wisconsin Hospital and ClinicsMadison, Wisconsin  53792-0001
Johns Hopkins University Medical CenterBaltimore, Maryland  21205
Duke University Medical Center United StatesDurham, North Carolina  27705