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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00570284

Enrollment

Registered

2007-12-10

Start date

2007-11-30

Completion date

2011-02-28

Last updated

2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Cancer, solid tumor, food effect, HDAC inhibitor, oral, LBH589

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

Interventions

DRUGLBH589

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)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame
Levels of LBH589 in the blood	every week for the first 3 weeks

Secondary

Measure	Time frame
Efficacy, Safety and tolerability	throughout study to 28 days after last treatment

Countries

Sweden, Switzerland, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026