Official Title: “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”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2009

Intervention(s) in this Clinical Trial

• Drug: LBH589 (i.v. panobinostat)
  • i.v. LBH589 dose levels: 10, 15, or 20 mg/m2 i.v. docetaxel 75 or 60 mg/m2 oral prednisone 5mg bid. LBH589 i.v. administered on days 1 and 8 in combination with docetaxel i.v. on day 1 and prednisone p.o 5mg bid every day of a 21-day cycle

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• To determine the MTD of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC
  • Time Frame: determine if MTD occurs after every 3 - 6 pts
    Safety Issue?: Yes

Secondary Measures

• To compare the PK profile of i.v. LBH589 with and without docetaxel
  • Time Frame: PK assessment will occur during the first 2 weeks of each pt treatment. Minor safety throughout the study treatment phase
    Safety Issue?: Yes
• To determine safety and tolerability of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC
  • Time Frame: PK assessment will occur during the first 2 weeks of each pt treatment
    Safety Issue?: Yes
• To determine preliminary activity of i.v. LBH589 in combination with docetaxel and prednisone
  • Time Frame: PK assessment will occur during the first 2 weeks of each pt treatment
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Study Chair Novartis  

Overall Contact: Novartis U.S. 862-778-8300 

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00663832

Study ID Number: CLBH589C2205

ClinicalTrials.gov Identifier: NCT00663832

Health Authority: United States: Food and Drug Administration