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”

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 Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2009

Intervention(s) in this Clinical Trial

• Drug: LBH589

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: LBH589

Primary Measures

• Pharmacokinetic (PK) parameters
  • Safety Issue?: Yes

Secondary Measures

• Response rate assessed by comparing tumor size via radiology scans (CTs or MRIs) Safety and tolerability (until disease progression, unacceptable toxicity or study completion) assessed by duration of patient participation

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

Inclusion 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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis Pharmeceuticals  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00535951

Study ID Number: CLBH589B2109

ClinicalTrials.gov Identifier: NCT00535951

Health Authority: Canada: Health Canada (Sante Canada)