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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Docetaxel; Hormones; Panobinostat; Prednisone

Criteria

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