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
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ClinicalTrials.gov Identifier: NCT00535951 |
Recruitment Status :
Completed
First Posted : September 27, 2007
Last Update Posted : December 19, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Carcinoma, Non-Small-Cell Lung Mesothelioma | Drug: LBH589 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | November 2007 |
Actual Primary Completion Date : | January 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: LBH589 |
Drug: LBH589 |
- Pharmacokinetic (PK) parameters [ Time Frame: first 10 days ]
- Response rate assessed by comparing tumor size via radiology scans (CTs or MRIs) [ Time Frame: day 10 through end of treatment ]
- 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 ]
- Tolerability (until disease progression, unacceptable toxicity or study completion) assessed by duration of patient participation [ Time Frame: day 10 through end of treatment ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00535951
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 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmeceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00535951 |
Other Study ID Numbers: |
CLBH589B2109 |
First Posted: | September 27, 2007 Key Record Dates |
Last Update Posted: | December 19, 2020 |
Last Verified: | November 2012 |
pleural mesothelioma mesothelioma Non-small cell lung cancer NSCLC lung cancer malignant |
advanced stage phase I LBH589 dextromethorphan CYP2D6 oral |
Mesothelioma Mesothelioma, Malignant Carcinoma, Non-Small-Cell Lung Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms |
Neoplasms by Site Pleural Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Panobinostat Antineoplastic Agents Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |