Phase 2
Completed N=35
Efficacy and Safety Study of Panobinostat in Participants With Metastatic Hormone Refractory Prostate Cancer
Source: ClinicalTrials.gov NCT00667862 ↗Enrolled (actual)
35
Serious AEs
40.0%
Results posted
Jun 2021
Primary outcomePrimary: Percentage of Participants With Progression-Free Survival (PFS) Rate at 24 Weeks — 11.4 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Progression-Free Survival (PFS) Rate at 24 Weeks |
11.4 | — |
| SECONDARY Percentage of Participants With Tumor Response Rate |
— | — |
| SECONDARY Percentage of Participants With Duration of Stable Disease (SD) Per RECIST |
— | — |
| SECONDARY Percentage of Participants With Prostate Specific Antigen (PSA) Response Rate at 24 Weeks |
— | — |
| SECONDARY Percentage of Participants With PSA Progression Rate at 24 Weeks |
48.6 | — |
| SECONDARY Median Progression-free Survival (PFS) |
— | — |
| SECONDARY Overall Survival |
— | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
35; 14 | — |
Eligibility Criteria
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:
- two or more lesions on bone scan
- progressive measurable disease
- 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.
Data sourced from ClinicalTrials.gov (NCT00667862). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.