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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00663832

Collaborator

(none)

Enrollment

Locations

Arm

4.9

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: LBH589 (i.v. panobinostat)	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LBH589	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 Other Names: Panobinostat

Arm

Intervention/Treatment

Experimental: LBH589

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

Other Names:

Panobinostat

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]
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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Rockville	Maryland	United States	20850
2	Novartis Investigative Site	Detroit	Michigan	United States	48201
3	Novartis Investigative Site	Saint Louis	Missouri	United States	63110
4	Novartis Investigative Site	Las Vegas	Nevada	United States	89135
5	Novartis Investigative Site	New York	New York	United States	10021
6	Novartis Investigative Site	Durham	North Carolina	United States	27710
7	Novartis Investigative Site	Portland	Oregon	United States	97239
8	Novartis Investigative Site	Vancouver	British Columbia	Canada	V5Z 1L8
9	Novartis Investigative Site	Hamilton	Ontario	Canada	L8V 5C2