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

Novartis

Status and phase: Completed; Phase 1

Conditions: Prostate Cancer

Treatments: Drug: LBH589 (i.v. panobinostat)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00663832

CLBH589C2205

2007-003315-30 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

LBH589

Experimental group

Treatment:

Drug: LBH589 (i.v. panobinostat)