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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

Primary Purpose

Carcinoma, Non-Small-Cell Lung, Mesothelioma

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

LBH589

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Non-small cell lung cancer, NSCLC, lung cancer, pleural mesothelioma, malignant, advanced stage, mesothelioma, phase I, LBH589, dextromethorphan, CYP2D6, oral

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Age ≥ 18 years
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
Must have failed prior standard systemic therapy
Must have at least one measurable and/or non-measurable lesion as defined by RECIST criteria
Baseline MUGA or ECHO must demonstrate LVEF ≥ the lower limit of the institutional normal.
Written informed consent obtained prior to any screening procedures
Willingness to have multiple blood draws
Ability to swallow capsules or tablets

Exclusion criteria:

Uncontrolled brain metastases
Prior treatment with an HDAC inhibitor
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
Concomitant use of any anti-cancer therapy, including radiation therapy
Significant cardiac disease
Concomitant use of drugs with a risk of causing torsades de pointes
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589
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

Sites / Locations

Highlands Oncology Group
Medical College of Georgia
RUSH Medical Center
MD Anderson Cancer Center
Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LBH589

Arm Description

Outcomes

Primary Outcome Measures

Pharmacokinetic (PK) parameters

Secondary Outcome Measures

Response rate assessed by comparing tumor size via radiology scans (CTs or MRIs)

Safety (until disease progression, unacceptable toxicity or study completion) assessed by duration of patient participation

Tolerability (until disease progression, unacceptable toxicity or study completion) assessed by duration of patient participation

Full Information

NCT ID

NCT00535951

First Posted

September 26, 2007

Last Updated

December 16, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00535951

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Non-Small-Cell Lung, Mesothelioma

Keywords

Non-small cell lung cancer, NSCLC, lung cancer, pleural mesothelioma, malignant, advanced stage, mesothelioma, phase I, LBH589, dextromethorphan, CYP2D6, oral

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LBH589

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

LBH589

Primary Outcome Measure Information:

Title

Pharmacokinetic (PK) parameters

Time Frame

first 10 days

Secondary Outcome Measure Information:

Title

Response rate assessed by comparing tumor size via radiology scans (CTs or MRIs)

Time Frame

day 10 through end of treatment

Title

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

Title

Tolerability (until disease progression, unacceptable toxicity or study completion) assessed by duration of patient participation

Time Frame

day 10 through end of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Age ≥ 18 years 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 Must have failed prior standard systemic therapy Must have at least one measurable and/or non-measurable lesion as defined by RECIST criteria Baseline MUGA or ECHO must demonstrate LVEF ≥ the lower limit of the institutional normal. Written informed consent obtained prior to any screening procedures Willingness to have multiple blood draws Ability to swallow capsules or tablets Exclusion criteria: Uncontrolled brain metastases Prior treatment with an HDAC inhibitor 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 Concomitant use of any anti-cancer therapy, including radiation therapy Significant cardiac disease Concomitant use of drugs with a risk of causing torsades de pointes Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmeceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Highlands Oncology Group

City

Fayetteville

State/Province

Arkansas

ZIP/Postal Code

72703

Country

United States

Facility Name

Medical College of Georgia

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

Facility Name

RUSH Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Novartis Investigative Site

City

Ontario

Country

Canada

12. IPD Sharing Statement

Links:

URL

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2855

Description

Results for CLBH589B2109 can be found on the Novartis Clinical Trial Results Website

Learn more about this trial

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

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