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Completed

NCT Number: NCT00790374

BN83495 in Prostate Cancer

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Johns Hopkins University Medical Center, Baltimore, Maryland, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BN83495 (Cohort 1)

Drug

20 mg daily BN83495 for 28 days

BN83495 (Cohort 2)

Drug

40 mg daily BN83495 for 28 days

BN83495 (Cohort 3)

Drug

60 mg daily BN83495 for 28 days

Primary outcomes

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

    Time frame: 28 days

Secondary outcomes

  1. Tolerance (Physical Exam, ECOG Performance Status, Electrocardiogram, biochemistry/haematology, Urinalysis, Adverse Events, Concomitant Medications, disease progression)

    Time frame: Each visit through day 28/29

  2. Pharmacokinetic assessments/Pharmacodynamic assessments

    Time frame: Pre-determined timepoints from baseline to day 28/29

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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

Acronym: STX64PC

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Nov 13, 2008
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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