A Dose Finding Study With I.V. Panobinostat (LBH589), Docetaxel, and Prednisone in Patients With Hormone Refractory Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00663832
• Other study ID #: CLBH589C2205
• Secondary ID: 2007-003315-30
• Status: Completed
• Phase: Phase 1
• Start date: February 2008

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Hamilton	Ontario
Canada	Novartis Investigative Site	Vancouver	British Columbia
United States	Novartis Investigative Site	Detroit	Michigan
United States	Novartis Investigative Site	Durham	North Carolina
United States	Novartis Investigative Site	Las Vegas	Nevada
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Rockville	Maryland
United States	Novartis Investigative Site	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the MTD of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC		determine if MTD occurs after every 3 - 6 pts
Secondary	To compare the PK profile of i.v. LBH589 with and without docetaxel		PK assessment will occur during the first 2 weeks of each pt treatment. Minor safety throughout the study treatment phase
Secondary	To determine safety and tolerability of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC		PK assessment will occur during the first 2 weeks of each pt treatment
Secondary	To determine preliminary activity of i.v. LBH589 in combination with docetaxel and prednisone		PK assessment will occur during the first 2 weeks of each pt treatment

External Links

•   Results for CLBH589C2205 can be found on the Novartis Clinical Trial Results Website