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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00503451
Other study ID # CLBH589B2110
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 2007

Study information

Verified date November 2012
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of this open-label study is to investigate the interaction of ketoconazole, a liver enzyme inhibitor, on oral LBH589 in adult patients with advanced solid tumors. The extension phase of the study will evaluate the safety and efficacy of LBH589 in patients with advanced solid tumors.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - Patients with histologically confirmed solid tumors or non-Hodgkin's lymphoma with progression on prior standard therapies. - Eastern Cooperative Oncology Group (ECOG) performance status of = 2 - Adequate kidney function and laboratory values Exclusion criteria: - Patients who have received chemotherapy, any investigational drug, undergone major surgery, or received wide field radiotherapy less than 4 weeks ago - Patients who had a heart attack or have unstable angina within past 6 months - Heart disease including congestive heart failure and uncontrolled high blood pressure - Liver disease, abnormal gastrointestinal (GI) function or ongoing diarrhea - Use of any anti-cancer therapy, including radiation therapy, or certain drugs while on study - Female patients who are pregnant or breast feeding. Other protocol inclusion/exclusion criteria may apply.

Study Design


Intervention

Drug:
LBH589


Locations

Country Name City State
Netherlands Novartis Investigative Site Rotterdam
United States Nevada Cancer Institute Las Vegas Nevada

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Levels of LBH589 in the blood on days 1, 5, 8, 9 and 10 of first cycle 2 weeks
Secondary Safety, tolerability and efficacy of oral LBH589 throughout the study at least every 2 months
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