Clinical trial NCT00570284: A Study to Investigate the Effect of Food on Oral LBH589 Absorption in 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Keywords: Cancer
solid tumor
food effect
HDAC inhibitor
oral
LBH589
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-12-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Levels of LBH589 in the blood
timeFrame: every week for the first 3 weeks
Secondary outcomes:
measure: Efficacy, Safety and tolerability
timeFrame: throughout study to 28 days after last treatment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Norwalk
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Rockville
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Boston
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Lebanon
country: United States
facility: Novartis Investigative Site
state: New Hampshire
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: Madison
country: United States
facility: Novartis Investigative Site
state: Wisconsin
city: Stokholm
country: Sweden
facility: Novartis Investigative Site
city: Zurich
country: Switzerland
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References: