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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Terminated

CT.gov ID

NCT00493766

Collaborator

(none)

Enrollment

Locations

Arms

3.2

Patients Per Site

Study Details

Study Description

Brief Summary

This is a parallel, two-arm, open-label, multicenter phase IA/IB study of LBH589 (oral formulation) alone and in combination with docetaxel in patients with progressing hormone refractory prostate cancer. This study is designed to determine the maximum tolerated dose of LBH589 as a single agent and in combination with docetaxel and prednisone 5 mg two times a day , and to characterize the safety, tolerability, biologic activity and pharmacokinetic profile

Condition or Disease	Intervention/Treatment	Phase
Hormone Refractory Prostate Cancer	Drug: LBH589	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase IA/IB, Two Arm, Multi-center, Open-label, Dose Escalation Study of Oral LBH589 Alone and in Combination With IV Docetaxel and Oral Prednisone in Hormone Refractory Prostate Cancer (HRPC)

Study Start Date :

May 1, 2006

Actual Primary Completion Date :

Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: oral LBH589 alone	Drug: LBH589
Experimental: oral LBH589 + IV docetaxel + oral prednisone	Drug: LBH589

Arm

Intervention/Treatment

Experimental: oral LBH589 alone

Drug: LBH589

Experimental: oral LBH589 + IV docetaxel + oral prednisone

Drug: LBH589

Outcome Measures

Primary Outcome Measures

• To determine the maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT) of esca-lating doses of LBH589 in adult men with HRPC. [at study start and at study end]
• To determine the MTD and DLT of escalating doses of LBH589 in combination with a stan-dard dose of docetaxel q3wks and daily Prednisone® in adult men with HRPC. [at study start and at study end]

Secondary Outcome Measures

• To characterize the safety and tolerability of LBH589 alone and in combination with do-cetaxel and Prednisone® including acute and chronic toxicities [at study start and at study end]
• To characterize the single-dose and multidose pharmacokinetic (PK) profiles of LBH589 alone and in combination with docetaxel and Prednisone®. To characterize the PK profiles of docetaxel alone and in combination with LBH589. [at study start and at study end]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Histologically documented adenocarcinoma of the prostate.
Patients must have metastatic disease with at least one measurable soft tissue lesion that can be assessed by computerized tomography (CT), or magnetic resonance imaging (MRI) and/or detectable lesion(s) on bone scintigraphy scan. Patients with only elevated prostate specific antegen (PSA) levels are not eligible for entry.
Patients who have undergone medical castration must continue Luteinizing hormone-releasing hormone (LHRH) agonist or antagonist therapy during study treatment
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115-6-84
2	Washing University School of Medicine	Saint Louis	Missouri	United States	63110
3	Nevada Cancer Institute	Las Vegas	Nevada	United States	89135
4	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
5	Duke University Medical Center	Durham	North Carolina	United States	27705