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

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

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

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Pharmacokinetic (PK) parameters

Secondary Outcome

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

Condition

Carcinoma, Non-Small-Cell Lung

Intervention

LBH589

Study Arms / Comparison Groups

 LBH589

Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

November 2007

Primary Completion Date

January 2009

Eligibility Criteria

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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Novartis Pharmaceuticals, ,

Location Countries

Canada

Location Countries

Canada

Administrative Informations

NCT ID

NCT00535951

Organization ID

CLBH589B2109

Responsible Party

Sponsor

Study Sponsor

Novartis Pharmaceuticals

Study Sponsor

Novartis Pharmaceuticals, Study Director, Novartis Pharmeceuticals

Verification Date

November 2012