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

NCT ID: NCT00503451

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Brief Summary

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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

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Conditions

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Non-Hodgkin Lymphoma Neoplasms

Keywords

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Advanced cancer solid tumors lymphoma HDAC LBH589 adults non-Hodgkin's lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LBH589

Group Type EXPERIMENTAL

LBH589

Intervention Type DRUG

Interventions

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LBH589

Intervention Type DRUG

Other Intervention Names

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Panobinostat

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Nevada Cancer Institute

Las Vegas, Nevada, United States

Site Status

Novartis Investigative Site

Rotterdam, , Netherlands

Site Status

Countries

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United States Netherlands

References

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Hamberg P, Woo MM, Chen LC, Verweij J, Porro MG, Zhao L, Li W, van der Biessen D, Sharma S, Hengelage T, de Jonge M. Effect of ketoconazole-mediated CYP3A4 inhibition on clinical pharmacokinetics of panobinostat (LBH589), an orally active histone deacetylase inhibitor. Cancer Chemother Pharmacol. 2011 Sep;68(3):805-13. doi: 10.1007/s00280-011-1693-x. Epub 2011 Jun 26.

Reference Type DERIVED
PMID: 21706316 (View on PubMed)

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=4102

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

Other Identifiers

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CLBH589B2110

Identifier Type: -

Identifier Source: org_study_id