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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00570284
• Other study ID #: CLBH589B2111
• Status: Completed
• Phase: Phase 1
• Start date: November 2007
• Est. completion date: February 2011

Study information

• Verified date: August 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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)

Locations

Country	Name	City	State
Sweden	Novartis Investigative Site	Stokholm
Switzerland	Novartis Investigative Site	Zurich
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Lebanon	New Hampshire
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Madison	Wisconsin
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	Norwalk	Connecticut
United States	Novartis Investigative Site	Rockville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of LBH589 in the blood		every week for the first 3 weeks
Secondary	Efficacy, Safety and tolerability		throughout study to 28 days after last treatment

External Links

•   Results for CLBH589B2111 on the Novartis Clinical Trials Website