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

Study Overview
=================
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

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

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: LBH589


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LBH589<br> | Drug: LBH589<br>* 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)<br>* Other names: Panobinostat;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of LBH589 in the blood |  | every week for the first 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy, Safety and tolerability |  | throughout study to 28 days after last treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, solid tumor, food effect, HDAC inhibitor, oral, LBH589