Mesothelioma Related Clinical Trials:
Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

   

Status: Recruiting
Sponsors and Collaborators: Novartis
Information provided by: Novartis
Government Identifier: NCT00535951

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


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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
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 or Metastatic Non-Small Cell Lung Cancer (NSCLC) or Malignant Pleural Mesothelioma

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

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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. At time of diagnosis or relapse, histologically confirmed NSCLC with locally advanced or metastatic disease (stage IIIA, IIIB, or IV) or histologically confirmed mesothelioma of the pleura which is unresectable
  3. Must have failed prior standard systemic therapy
    • NSCLC patients must have failed at least two prior therapies, including a platinum-based chemotherapy regimen
    • Malignant Pleural Mesothelioma patients must have failed at least one pemetrexed- or cisplatin-based chemotherapy regimen
  4. Must have measurable disease (by computerized tomography [CT] or magnetic resonance imaging [MRI]) per disease specific criteria (RECIST criteria for NSCLC and modified RECIST criteria for mesothelioma)
  5. Mesothelioma patients may have undergone pleurodesis
  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. Known 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 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

Other protocol-defined inclusion/exclusion criteria may apply


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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, 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    

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Additional Information:

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

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

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

Additional relevant MeSH terms:
Mesothelioma
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
Respiratory Tract Diseases
Therapeutic Uses
Antitussive Agents
Central Nervous System Agents
Excitatory Amino Acid Antagonists

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