Mesothelioma Related Clinical Trials:
Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
  Â
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: Â |
Interventional |
| Study Design: Â |
Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
|
| Official Title: Â |
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: Â |
24 |
| Study Start Date: Â |
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
- Age ≥ 18 years
- 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
- 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
- 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)
- Mesothelioma patients may have undergone pleurodesis
- Written informed consent obtained prior to any screening procedures
- Willingness to have multiple blood draws
- Ability to swallow capsules or tablets
Exclusion criteria
- Known brain metastases
- Prior treatment with an HDAC inhibitor
- 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
- 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
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. Â Â |
800 340 6843 Â Â |
|
|
| Contact: Novartis Basel   |
41 61 324 1111 Â Â |
|
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
Investigators
|
| Study Chair: Â Â |
Novartis   |
Novartis   |
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Additional Information:
| Study ID Numbers: Â |
CLBH589B2109 |
| First Received: Â |
September 26, 2007 |
| Last Updated: Â |
September 26, 2007 |
| ClinicalTrials.gov Identifier: Â |
NCT00535951 |
| Health Authority: Â |
Canada: Health Canada (Sante Canada); Â United States: Food and Drug Administration |
Keywords provided by Novartis:
| pleural mesothelioma  |
| mesothelioma  |
| Pleural Mesothelioma  |
| Non-small cell lung cancer  |
| NSCLC Â |
| 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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