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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00790374

Acronym

STX64PC

Enrollment

Registered

2008-11-13

Start date

2009-01-31

Completion date

2011-02-28

Last updated

2019-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Pharmacodynamic profile and safety of BN83495

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

Interventions

DRUGBN83495 (Cohort 1)

20 mg daily BN83495 for 28 days

DRUGBN83495 (Cohort 2)

40 mg daily BN83495 for 28 days

DRUGBN83495 (Cohort 3)

60 mg daily BN83495 for 28 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Absolute and percentage change in levels of hormones from baseline to D28/29 at 6 timepoints	28 days

Secondary

Measure	Time frame
Tolerance (Physical Exam, ECOG Performance Status, Electrocardiogram, biochemistry/haematology, Urinalysis, Adverse Events, Concomitant Medications, disease progression)	Each visit through day 28/29
Pharmacokinetic assessments/Pharmacodynamic assessments	Pre-determined timepoints from baseline to day 28/29

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026