Clinical trial · Interventional
Efficacy and Safety Study of Panobinostat in Participants With Metastatic Hormone Refractory Prostate Cancer
A Phase II, Open Label, Single Arm Study of i.v. Panobinostat (LBH589) in Patients With Metastatic Hormone Refractory Prostate Cancer
NCT00667862CI-TRIAL-00052361completedPhase 2Results postedClinicalTrials.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 II single dose study was designed to characterize the safety, tolerability, and efficacy of intravenous (i.v.) panobinostat as a single-agent treatment in participants 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 |
|---|---|---|---|
| Panobinostat | Drug | Panobinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Panobinostat
- description
- Participants with metastatic hormone refractory prostate cancer received 20 milligrams per meter square (mg/m\^2) of panobinostat intravenously (i.v.) on Days 1 and 8 of a 21-day cycle. Treatment continued until disease progression as per investigator, intolerable toxicity, start of new cancer therapy, death, or withdrawal of consent.
- interventionNames
- Drug: Panobinostat
Primary outcomes (1)
- measure
- Percentage of Participants With Progression-Free Survival (PFS) Rate at 24 Weeks
- timeFrame
- 24 weeks
- description
- The PFS rate was defined as the percentage of participants that were alive without documented disease progression at the end of 24 weeks from first study treatment. Disease Progression as per response evaluation criteria in solid tumors (RECIST) criteria: Measurable lesions: If target lesion was lymph node then it had to be at least 2 centimeter (cm) at baseline to assess change in size. Bone lesions: (non-target lesions) appearance of greater than or equal to (\>=) 2 unequivocal new lesions confirmed on a second scan at least 6 weeks later.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Confirmed diagnosis of adenocarcinoma of the prostate * Participants with metastatic hormone refractory prostate cancer * Participants that have had at least one, but not more than two prior cytotoxic treatments for prostate cancer * Evidence of disease progression by at least one of the following: 1. two or more lesions on bone scan 2. progressive measurable disease 3. two documented increases in prostate-specific antigen (PSA) * Willing to use contraception throughout the study and for 12 weeks after study completion Exclusion criteria: * History or clinical signs of central nervous system (CNS) disease * 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 function Other protocol-defined inclusion/exclusion criteria may apply.
References
Publications (1)
- BACKGROUNDRathkopf DE, Picus J, Hussain A, Ellard S, Chi KN, Nydam T, Allen-Freda E, Mishra KK, Porro MG, Scher HI, Wilding G. A phase 2 study of intravenous panobinostat in patients with castration-resistant prostate cancer. Cancer Chemother Pharmacol. 2013 Sep;72(3):537-44. doi: 10.1007/s00280-013-2224-8. Epub 2013 Jul 3. PMID 23820963