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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

Thank you

Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Levels of LBH589 in the blood

Outcome Time Frame:

every week for the first 3 weeks

Safety Issue:

No

Principal Investigator

Novartis

Investigator Role:

Study Chair

Investigator Affiliation:

Novartis

Authority:

Sweden: Regional Ethical Review Board

Study ID:

CLBH589B2111

NCT ID:

NCT00570284

Start Date:

November 2007

Completion Date:

February 2011

Related Keywords:

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

Name

Location

Novartis Investigative Site Boston, Massachusetts  02115
Novartis Investigative Site Sacramento, California  95817
Novartis Investigative Site Lebanon, New Hampshire  03756
Novartis Investigative Site Buffalo, New York  14263
Novartis Investigative Site Madison, Wisconsin  53792
Novartis Investigative Site Baltimore, Maryland  21201
Novartis Investigative Site Norwalk, Connecticut  06856