NCT00535951

Brief Summary

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

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Last Updated

December 19, 2020

Status Verified

November 1, 2012

Enrollment Period

1.2 years

First QC Date

September 26, 2007

Last Update Submit

December 16, 2020

Conditions

Carcinoma, Non-Small-Cell LungMesothelioma

Keywords

Non-small cell lung cancerNSCLClung cancerpleural mesotheliomamalignantadvanced stagemesotheliomaphase ILBH589dextromethorphanCYP2D6oral

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic (PK) parameters

    first 10 days

Secondary Outcomes (3)

  • Response rate assessed by comparing tumor size via radiology scans (CTs or MRIs)

    day 10 through end of treatment

  • Safety (until disease progression, unacceptable toxicity or study completion) assessed by duration of patient participation

    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

    day 10 through end of treatment

Study Arms (1)

LBH589

EXPERIMENTAL
Drug: LBH589

Interventions

LBH589DRUG
LBH589

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Highlands Oncology Group

Fayetteville, Arkansas, 72703, United States

Location

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

RUSH Medical Center

Chicago, Illinois, 60612, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Novartis Investigative Site

Ontario, Canada

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungMesotheliomaLung NeoplasmsMesothelioma, Malignant

Interventions

Panobinostat

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, MesothelialPleural Neoplasms

Intervention Hierarchy (Ancestors)

Hydroxamic AcidsHydroxylaminesAminesOrganic ChemicalsHydroxy AcidsCarboxylic AcidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmeceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2007

First Posted

September 27, 2007

Study Start

November 1, 2007

Primary Completion

January 1, 2009

Last Updated

December 19, 2020

Record last verified: 2012-11

Locations

US(4)CA(1)