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A Clinical Trial of Vorinostat (MK0683, SAHA) in Combination With FDA Approved Cancer Drugs in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)(0683-056)

NCT00473889 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2015-07-03

Study results available
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Summary

This Phase III clinical trial which incorporates an initial Phase II component will determine the survival of advanced Non-small cell lung cancer patients when treated with MK0683 and paclitaxel plus carboplatin

Conditions

  • Stage IIIB or IV Non-Small Cell Lung Cancer

Interventions

DRUG

vorinostat

vorinostat 400 mg capsules once daily. Up to 6 months of treatment

DRUG

Comparator: paclitaxel

intravenous (IV) paclitaxel 200 mg/m2. Up to 6 months of treatment

DRUG

Comparator: carboplatin

intravenous (IV) carboplatin AUC 6mg/min/ml. Up to 6 months of treatment.

DRUG

Comparator: placebo

vorinostat 400 mg placebo capsules once daily. Up to 6 months of treatment

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-12-31
Completion
2008-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00473889 on ClinicalTrials.gov