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A Phase I/II Clinical Trial of Vorinostat in Combination With Erlotinib for Patients With Relapsed/Refractory Non-Small-Cell Lung Cancer (0683-025)

NCT00251589 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2015-03-06

Study results available
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Summary

The reason for this study will be to find the safest maximum tolerated dose of oral vorinostat in combination with erlotinib \[Tarceva (TM)\] that can be given to patients with lung cancer who have relapsed or failed other therapy for the disease. Once the safest maximum tolerated dose of vorinostat is determined, patients enrolled in the clinical trial will continue vorinostat and erlotinib for up to 8 months. Safety and effectiveness will also be evaluated.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Vorinostat

Vorinostat 200 mg twice a day for 3 days a week.

DRUG

Vorinostat

Vorinostat 300 mg once a day for 3 days a week.

DRUG

Vorinostat

Vorinostat 300 mg twice a day for 3 days a week.

DRUG

Vorinostat

Vorinostat 400 mg once a day for 21 out of 28 days.

DRUG

erlotinib

erlotinib 150 mg once a day.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2007-10-31
Completion
2007-10-31

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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 NCT00251589 on ClinicalTrials.gov