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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

This study is currently recruiting participants.
Verified by Novartis, July 2008

Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00535951
  Purpose

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


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Mesothelioma
Drug: LBH 589
Phase I

MedlinePlus related topics:   Cancer    Lung Cancer    Mesothelioma   

Drug Information available for:   Dextromethorphan    Dextromethorphan hydrobromide    Levomethorphan    Racemethorphan   

U.S. FDA Resources

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

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Pharmacokinetic (PK) parameters Safety and tolerability (days 1-10) assessed by AEs, SAEs, labs, ECG reports, radiology reports.

Secondary Outcome 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

Estimated Enrollment:   24
Study Start Date:   September 2007

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535951

Contacts
Contact: Novartis U.S.     800 340 6843    
Contact: Novartis Basel     41 61 324 1111    

Locations
United States, Arkansas
Highlands Oncology Group     Recruiting
      Fayetteville, Arkansas, United States, 72703
      Contact: Kim Davison     479-587-1700 ext 4171     kdavison@hogonc.com    
      Principal Investigator: J. T. Beck, M.D            
United States, Georgia
Medical College of Georgia     Not yet recruiting
      Augusta, Georgia, United States, 30912
      Contact: Eileen Dickman     706-721-1599     edickman@mail.mcg.edu    
      Principal Investigator: Asha Nayak, M.D.            
United States, Illinois
RUSH Medical Center     Recruiting
      Chicago, Illinois, United States
      Contact: Robert Bonomi, M.D.            
United States, Texas
MD Anderson Cancer Center     Recruiting
      Houston, Texas, United States
      Contact: Vali Papa, M.D.            
Canada
Recruiting
      Ontario, Canada

Sponsors and Collaborators
Novartis

Investigators
Study Chair:     Novartis     Novartis    
  More Information


Study ID Numbers:   CLBH589B2109
First Received:   September 26, 2007
Last Updated:   July 7, 2008
ClinicalTrials.gov Identifier:   NCT00535951
Health Authority:   Canada: Health Canada (Sante Canada);   United States: Food and Drug Administration

Keywords provided by Novartis:
Non-small cell lung cancer  
NSCLC  
lung cancer  
pleural mesothelioma  
malignant  
advanced stage  
mesothelioma  
phase I
LBH589
dextromethorphan
CYP2D6
oral
Non-small Cell Lung Cancer
Pleural Mesothelioma

Study placed in the following topic categories:
Thoracic Neoplasms
Excitatory Amino Acids
Non-small cell lung cancer
Carcinoma
Naphazoline
Oxymetazoline
Respiratory Tract Diseases
Guaifenesin
Lung Neoplasms
Phenylephrine
Lung Diseases
Dextromethorphan
Mesothelioma
Phenylpropanolamine
Carcinoma, Non-Small-Cell Lung
Adenoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory System Agents
Respiratory Tract Neoplasms
Neurotransmitter Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Neoplasms, Mesothelial
Physiological Effects of Drugs
Excitatory Amino Acid Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Antitussive Agents
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on November 20, 2008




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