BN83495 in Prostate Cancer (STX64PC)

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00790374
First received: November 11, 2008
Last updated: February 28, 2011
Last verified: February 2011

November 11, 2008
February 28, 2011
January 2009
October 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00790374 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
BN83495 in Prostate Cancer
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

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

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

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • 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
  • Experimental: Cohort 1
    6 patients have been enrolled, the cohort has been completed.
    Intervention: Drug: BN83495 (Cohort 1)
  • Experimental: Cohort 2
    6 patients have been enrolled in cohort 2, the cohort has been completed.
    Intervention: Drug: BN83495 (Cohort 2)
  • Experimental: Cohort 3
    5 patients have been enrolled in cohort 3. The cohort was closed after the 5th patient enrolled.
    Intervention: Drug: BN83495 (Cohort 3)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
February 2011
October 2010   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00790374
X-52-58064-003
Yes
Eric Chetaille MD, Ipsen
Ipsen
Not Provided
Study Director: Eric Chetaille, MD Ipsen
Ipsen
February 2011

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