Trial record 3 of 4 for:
mesothelioma AND Arkansas
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 has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00535951
First received: September 26, 2007
Last updated: November 26, 2012
Last verified: November 2012
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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
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Non-Small-Cell Lung Mesothelioma |
Drug: LBH589 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Pharmacokinetic (PK) parameters [ Time Frame: first 10 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Response rate assessed by comparing tumor size via radiology scans (CTs or MRIs) [ Time Frame: day 10 through end of treatment ] [ Designated as safety issue: No ]
- Safety (until disease progression, unacceptable toxicity or study completion) assessed by duration of patient participation [ Time Frame: first 10 days, day 10 through end of treatment plus follow-up ] [ Designated as safety issue: Yes ]
- Tolerability (until disease progression, unacceptable toxicity or study completion) assessed by duration of patient participation [ Time Frame: day 10 through end of treatment ] [ Designated as safety issue: Yes ]
| Enrollment: | 18 |
| Study Start Date: | November 2007 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: LBH589 | Drug: LBH589 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Age ≥ 18 years
- 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
- Must have failed prior standard systemic therapy
- Must have at least one measurable and/or non-measurable lesion as defined by RECIST criteria
- Baseline MUGA or ECHO must demonstrate LVEF ≥ the lower limit of the institutional normal.
- Written informed consent obtained prior to any screening procedures
- Willingness to have multiple blood draws
- Ability to swallow capsules or tablets
Exclusion criteria:
- Uncontrolled brain metastases
- Prior treatment with an HDAC inhibitor
- 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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535951
Locations
| United States, Arkansas | |
| Highlands Oncology Group | |
| Fayetteville, Arkansas, United States, 72703 | |
| United States, Georgia | |
| Medical College of Georgia | |
| Augusta, Georgia, United States, 30912 | |
| United States, Illinois | |
| RUSH Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Canada | |
| Novartis Investigative Site | |
| Ontario, Canada | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmeceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00535951 History of Changes |
| Other Study ID Numbers: | CLBH589B2109 |
| Study First Received: | September 26, 2007 |
| Last Updated: | November 26, 2012 |
| 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 |
Additional relevant MeSH terms:
|
Mesothelioma Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |
Adenoma Neoplasms, Mesothelial Dextromethorphan Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antitussive Agents Central Nervous System Agents Therapeutic Uses Respiratory System Agents |
ClinicalTrials.gov processed this record on May 16, 2013