| September 26, 2007 |
| September 21, 2009 |
| November 2007 |
| January 2009 (final data collection date for primary outcome measure) |
| Pharmacokinetic (PK) parameters [ Designated as safety issue: Yes ] |
| Pharmacokinetic (PK) parameters
Safety and tolerability (days 1-10) assessed by AEs, SAEs, labs, ECG reports, radiology reports. |
| Complete list of historical versions of study NCT00535951 on ClinicalTrials.gov Archive Site |
| 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 |
| Same as current |
| |
| 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 |
| 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 |
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 |
| |
| Phase I |
| Interventional |
| Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
- Carcinoma, Non-Small-Cell Lung
- Mesothelioma
|
| Drug: LBH589 |
| |
| |
| |
| Completed |
| 18 |
|
| January 2009 (final data collection date for primary outcome measure) |
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
Inclusion 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
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Canada |
| |
| NCT00535951 |
| External Affairs, Novartis Pharmaceuticals |
| CLBH589B2109 |
| Novartis Pharmaceuticals |
|
| Study Director: |
Novartis Pharmaceuticals |
Novartis Pharmeceuticals |
|
|
| Novartis |
| May 2009 |
