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

NCT00570284 | Completed Phase 1

• 1 other identifier: CLBH589B2111
• Study Type: interventional
• Target: 36
• Locations: 3 countries
• Sites: 9

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

Conditions

Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Levels of LBH589 in the blood

  every week for the first 3 weeks

Secondary Outcomes (1)

• Efficacy, Safety and tolerability

  throughout study to 28 days after last treatment

Study Arms (1)

LBH589

EXPERIMENTAL

Drug: LBH589

Interventions

LBH589 DRUG

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)

Also known as: Panobinostat

LBH589

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (9)

Novartis Investigative Site

Los Angeles, California, United States

Location

Novartis Investigative Site

Norwalk, Connecticut, United States

Location

Novartis Investigative Site

Rockville, Maryland, United States

Location

Novartis Investigative Site

Boston, Massachusetts, United States

Location

Novartis Investigative Site

Lebanon, New Hampshire, United States

Location

Novartis Investigative Site

New York, New York, United States

Location

Novartis Investigative Site

Madison, Wisconsin, United States

Location

Novartis Investigative Site

Stockholm, Sweden

Location

Novartis Investigative Site

Zurich, Switzerland

Location

Related Links

• Results for CLBH589B2111 on the Novartis Clinical Trials Website

MeSH Terms

Conditions

Neoplasms

Interventions

Panobinostat

Intervention Hierarchy (Ancestors)

Hydroxamic Acids; Hydroxylamines; Amines; Organic Chemicals; Hydroxy Acids; Carboxylic Acids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Novartis

  Novartis

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2007
• First Posted: December 10, 2007
• Study Start: November 1, 2007
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: December 19, 2020

Record last verified: 2016-08

Locations

US (7); SE (1); CH (1)