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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung, Mesothelioma

Thank you

Trial Information

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

Inclusion Criteria


Inclusion criteria:

1. Age ≥ 18 years

2. 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

3. Must have failed prior standard systemic therapy

4. Must have at least one measurable and/or non-measurable lesion as defined by RECIST
criteria

5. Baseline MUGA or ECHO must demonstrate LVEF ≥ the lower limit of the institutional
normal.

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. Uncontrolled 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 not 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pharmacokinetic (PK) parameters

Outcome Time Frame:

first 10 days

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmeceuticals

Authority:

Canada: Health Canada (Sante Canada)

Study ID:

CLBH589B2109

NCT ID:

NCT00535951

Start Date:

November 2007

Completion Date:

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Mesothelioma
  • Non-small cell lung cancer
  • NSCLC
  • lung cancer
  • pleural mesothelioma
  • malignant
  • advanced stage
  • mesothelioma
  • phase I
  • LBH589
  • dextromethorphan
  • CYP2D6
  • oral
  • Non-small Cell Lung Cancer
  • Pleural Mesothelioma
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Mesothelioma

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Highlands Oncology GroupSpringdale, Arkansas  72764
Medical College of GeorgiaAugusta, Georgia  30912
Rush Medical CenterChicago, Illinois  60612