Clinical trial · Interventional
A Dose Finding Study With I.V. Panobinostat (LBH589), Docetaxel, and Prednisone in Patients With Hormone Refractory Prostate Cancer
An Open Label, Single Arm, Phase Ib Dose Finding Study of i.v. Panobinostat (LBH589) With Docetaxel and Prednisone in Patients With Hormone Refractory Prostate Cancer
NCT00663832CI-TRIAL-00048987completedPhase 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)
This Phase Ib dose escalation study is designed to characterize the safety, tolerability and preliminary efficacy of i.v. panobinostat (LBH589) in combination with docetaxel and prednisone in the 1st line treatment of patients with hormone refractory prostate cancer.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LBH589 (i.v. panobinostat) | Drug | Panobinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LBH589
- interventionNames
- Drug: LBH589 (i.v. panobinostat)
Primary outcomes (1)
- measure
- To determine the MTD of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC
- timeFrame
- determine if MTD occurs after every 3 - 6 pts
Secondary outcomes (3)
- measure
- To compare the PK profile of i.v. LBH589 with and without docetaxel
- timeFrame
- PK assessment will occur during the first 2 weeks of each pt treatment. Minor safety throughout the study treatment phase
- measure
- To determine safety and tolerability of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * HRPC patients * Evidence of disease progression * Self care, able to perform light work activities * Willing to use contraception throughout the study and for 12 weeks after study completion Exclusion criteria: * History of other cancers not curatively treated with no evidence of disease for more than 5 years. * Prior radiotherapy within 3 weeks of starting study treatment * Prior radiopharmaceuticals (strontium, samarium). * Impaired cardiac function * Heart disease * Liver or renal disease with impaired functions. Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.