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Study to Evaluate Erlotinib With or Without SNDX-275 (Entinostat) in the Treatment of Patients With Advanced NSCLC

NCT00602030 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2022-08-22

Study results available
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Summary

The purpose of this study is to evaluate the safety and efficacy of entinostat in combination with erlotinib in the treatment of Advanced Non-Small Cell Lung Cancer (NSCLC).

Conditions

  • Non-Small-Cell Lung Carcinoma
  • Carcinoma, Non-Small Cell Lung

Interventions

DRUG

Entinostat

Entinostat tablets on Days 1 and 15 of a 28-day cycle.

DRUG

Placebo

Placebo-matching entinostat tablets on Days 1 and 15 of a 28-day cycle.

DRUG

Erlotinib

Erlotinib 150 mg tablets once daily.

Sponsors & Collaborators

Principal Investigators

  • Samir Witta, MD · Rocky Mountain Cancer Centers

  • Kartik Konduri, MD · Texas Oncology - Sammons Cancer Center

  • Robert Raju, MD · Dayton Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-08
Primary Completion
2010-02-04
Completion
2012-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00602030 on ClinicalTrials.gov