A Study to Investigate the Effects of Ketoconazole on LBH589 in Patients With Advanced Solid Tumors

Neoplasms Clinical Trial

Official title:

A Phase IB, Study to Investigate the Effect of Ketoconazole, a CYP3A4 Inhibitor, on Oral LBH589 and to Assess the Efficacy and Safety of Oral LBH589 in Patients With Advanced Solid Tumors.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00503451
• Other study ID #: CLBH589B2110
• Status: Completed
• Phase: Phase 1
• Start date: September 2007

Study information

• Verified date: November 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• 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. 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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Neoplasms
• Non-Hodgkin Lymphoma

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

External Links

•   Results for CLBH589B2110 can be found on the Novartis Clinical Trial Results Website