Efficacy and Safety Study of Panobinostat in Participants With Metastatic Hormone Refractory Prostate Cancer

Novartis

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Panobinostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT00667862

2007-004995-37 (EudraCT Number)

CLBH589C2208

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Panobinostat

Experimental group

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.

Treatment:

Drug: Panobinostat