Clinical trial · Interventional
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
NCT00790374CI-TRIAL-00036560STX64PCcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BN83495 (Cohort 1) | Drug | — | UNRESOLVED |
| BN83495 (Cohort 2) | Drug | — | UNRESOLVED |
| BN83495 (Cohort 3) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- 6 patients have been enrolled, the cohort has been completed.
- interventionNames
- Drug: BN83495 (Cohort 1)
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- 6 patients have been enrolled in cohort 2, the cohort has been completed.
- interventionNames
- Drug: BN83495 (Cohort 2)
- type
- EXPERIMENTAL
- label
- Cohort 3
- description
- 5 patients have been enrolled in cohort 3. The cohort was closed after the 5th patient enrolled.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.