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COMPLETEDPHASE1

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

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.

NCT00503451•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (2)

Nevada Cancer Institute

Las Vegas, Nevada, United States

Novartis Investigative Site

Rotterdam, Netherlands

Key Dates

Start Date

September 1, 2007

Primary Completion Date

April 1, 2010

Last Updated

December 19, 2020

Enrollment

ACTUAL participants

Conditions

Non-Hodgkin LymphomaNeoplasms

Interventions

LBH589

DRUG

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer

A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer

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