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

Phase 1

Completed

• Conditions: Non-Hodgkin Lymphoma; Neoplasms
• Interventions: Drug: LBH589

• Registration Number: NCT00503451
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-07-17
• Study First Submitted QC: 2007-07-17
• Study First Posted: 2007-07-18
• Study Start: 2007-09
• Primary Completion: 2010-04
• Status Verified: 2012-11
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LBH589	LBH589	-

Primary Outcome Measures

Name	Time	Method
Levels of LBH589 in the blood on days 1, 5, 8, 9 and 10 of first cycle	2 weeks

Secondary Outcome Measures

Name	Time	Method
Safety, tolerability and efficacy of oral LBH589 throughout the study	at least every 2 months

Trial Locations

Locations (2)

Nevada Cancer Institute; 🇺🇸 Las Vegas, Nevada, United States

Novartis Investigative Site; 🇳🇱 Rotterdam, Netherlands