A Study to Investigate the Effect of Food on Oral LBH589 Absorption in Patients With Advanced Solid Tumors

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00570284

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary purpose of this study is to evaluate the effect of food on oral LBH589 in adult patients with advanced solid tumors. This study will also evaluate the safety and efficacy of LBH589 in adult patients with advanced solid tumors

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

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase Ib Open-label, Multicenter Cross-over Study to Investigate the Effect of Food on the Rate and Extent of Oral LBH589 Absorption in Patients With Advanced Solid Tumors

Study Start Date :

Nov 1, 2007

Actual Primary Completion Date :

Feb 1, 2011

Actual Study Completion Date :

Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LBH589	Drug: LBH589 orally administered panobinostat at 20 mg twice weekly (core phase); orally administered panobinostat 45 mg twice weekly if 20 mg twice weekly was tolerated in Cycle 1 (extension phase) Other Names: Panobinostat

Arm

Intervention/Treatment

Experimental: LBH589

Drug: LBH589

orally administered panobinostat at 20 mg twice weekly (core phase); orally administered panobinostat 45 mg twice weekly if 20 mg twice weekly was tolerated in Cycle 1 (extension phase)

Other Names:

Panobinostat

Outcome Measures

Primary Outcome Measures

Levels of LBH589 in the blood [every week for the first 3 weeks]

Secondary Outcome Measures

Efficacy, Safety and tolerability [throughout study to 28 days after last treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists
Age ≥ 18 years old
Patients must have adequate laboratory values
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Ability to swallow capsules or tablets

Exclusion criteria:

Patients with active central nervous system (CNS) disease or brain metastases except those who have been previously treated and have been stable for at least 3 months.
Patients with a second primary malignancy that is currently clinically significant or requiring active intervention
Impaired heart function or clinically significant heart disease
Impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of LBH589
Ongoing diarrhea
Liver or renal disease with impaired hepatic or renal functions
Concomitant use of any anti-cancer therapy or certain drugs
Female patients who are pregnant or breast feeding
Patients not willing to use an effective method of birth control

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country
1	Novartis Investigative Site	Los Angeles	California	United States
2	Novartis Investigative Site	Norwalk	Connecticut	United States
3	Novartis Investigative Site	Rockville	Maryland	United States
4	Novartis Investigative Site	Boston	Massachusetts	United States
5	Novartis Investigative Site	Lebanon	New Hampshire	United States
6	Novartis Investigative Site	New York	New York	United States
7	Novartis Investigative Site	Madison	Wisconsin	United States
8	Novartis Investigative Site	Stokholm		Sweden
9	Novartis Investigative Site	Zurich		Switzerland