Pharmacokinetic, Safety, and Efficacy Effects of Oral LBH589 on Dextromethorphan in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer or Malignant Pleural Mesothelioma

December 16, 2020 updated by: Novartis Pharmaceuticals

A Phase IB, Open-Label, Multicenter Study to Investigate the Effect of Oral LBH589 on Dextromethorphan, a CYP2D6 Substrate, and to Assess the Efficacy and Safety of Oral LBH589 in Patients With Advanced Solid Tumors

This study will investigate the effect of oral LBH589 on dextromethorphan, a CYP2D6 substrate, and to assess safety and efficacy of oral LBH589 when used with this co-medication in advanced stage NSCLC or malignant pleural mesothelioma patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Ontario, Canada
        • Novartis Investigative Site
  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Highlands Oncology Group
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Medical College of Georgia
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Md Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Age ≥ 18 years
  2. Must have histologically or cytologically confirmed advanced or metastatic incurable solid tumor as documented by CT or MRI that has progressed on or following standard therapies
  3. Must have failed prior standard systemic therapy
  4. Must have at least one measurable and/or non-measurable lesion as defined by RECIST criteria
  5. Baseline MUGA or ECHO must demonstrate LVEF ≥ the lower limit of the institutional normal.
  6. Written informed consent obtained prior to any screening procedures
  7. Willingness to have multiple blood draws
  8. Ability to swallow capsules or tablets

Exclusion criteria:

  1. Uncontrolled brain metastases
  2. Prior treatment with an HDAC inhibitor
  3. Presence of clinically detectable third-space fluid collections (e.g., ascites or pleural effusions) that can not be controlled by drainage or other procedures prior to study entry
  4. Concomitant use of any anti-cancer therapy, including radiation therapy
  5. Significant cardiac disease
  6. Concomitant use of drugs with a risk of causing torsades de pointes
  7. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589
  8. Previous use of monoamine oxidase inhibitors (e.g. clorgyline, iproniazid, isocarboxazid, moclobemide, sibutramine, phenelzine, tranylcypromine) within 14 days prior to the first dose of dextromethorphan

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LBH589
Drug: LBH589

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic (PK) parameters
Time Frame: first 10 days
first 10 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Response rate assessed by comparing tumor size via radiology scans (CTs or MRIs)
Time Frame: day 10 through end of treatment
day 10 through end of treatment
Safety (until disease progression, unacceptable toxicity or study completion) assessed by duration of patient participation
Time Frame: first 10 days, day 10 through end of treatment plus follow-up
first 10 days, day 10 through end of treatment plus follow-up
Tolerability (until disease progression, unacceptable toxicity or study completion) assessed by duration of patient participation
Time Frame: day 10 through end of treatment
day 10 through end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

September 26, 2007

First Submitted That Met QC Criteria

September 26, 2007

First Posted (Estimate)

September 27, 2007

Study Record Updates

Last Update Posted (Actual)

December 19, 2020

Last Update Submitted That Met QC Criteria

December 16, 2020

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLBH589B2109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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