Safety of LBH589 Alone and in Combination With Intravenous Docetaxel and Prednisone

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

Summary

This 2-arm study is designed to determine the maximum tolerated dose of LBH589 as a single agent and in combination with docetaxel and prednisone 5 mg twice daily (second arm) and to characterize the safety, tolerability, biologic activity and pharmacokinetic profile.

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

Details

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

Criteria

Inclusion Criteria:

• Patients with hormone refractory prostate cancer

• Patients must have metastatic disease with at least 1 measurable soft tissue lesion that can be assessed by CT or MRI and/or detectable lesion(s) on bone scintigraphy scan. Patients with only elevated PSA levels are not eligible for entry.

• Patients must meet laboratory inclusion criteria defined in the protocol

• Patients must be able to provide written informed consent

Exclusion Criteria:

• Patients with prior or concurrent brain metastases

• Impaired cardiac, gastrointestinal, kidney or liver function

• Use of therapeutic androgens Other protocol-defined inclusion/exclusion criteria may apply