Clinical trial NCT00667862: Efficacy and Safety Study of Panobinostat in Participants With Metastatic Hormone Refractory Prostate Cancer
Official title: A Phase II, Open Label, Single Arm Study of i.v. Panobinostat (LBH589) in Patients With Metastatic Hormone Refractory Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate
Cancer
Adenocarcinoma
Prostate-Specific Antigen
metastatic
male
HRPC
DACi
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-04-28
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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:

  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.

Primary outcomes:
measure: Percentage of Participants With Progression-Free Survival (PFS) Rate at 24 Weeks
timeFrame: 24 weeks
Secondary outcomes:
measure: Percentage of Participants With Tumor Response Rate
timeFrame: Every 12 weeks up to approximately 2.7 years
measure: Percentage of Participants With Duration of Stable Disease (SD) Per RECIST
timeFrame: Every 12 weeks up to approximately 2.7 years
measure: Percentage of Participants With Prostate Specific Antigen (PSA) Response Rate at 24 Weeks
timeFrame: 24 weeks
measure: Percentage of Participants With PSA Progression Rate at 24 Weeks
timeFrame: 24 weeks
measure: Median Progression-free Survival (PFS)
timeFrame: After every cycle up to approximately 2.7 years
measure: Overall Survival
timeFrame: Start of study treatment to date of death due to any cause (Up to approximately 2.7 years)
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From start of the study up to at least 4 weeks following the last dose of study treatment (Up to approximately 2.7 years)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Rathkopf 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.