NCT00602030

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

A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 2 Study With a Lead in Phase of Erlotinib With or Without SNDX-275 in Patients With NSCLC After Failure In Up to Two Prior Chemotherapeutic Regimens for Advanced Disease

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Syndax Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2008-01-08
• Primary completion: 2010-02-04
• Completion: 2012-02-01
• First posted: 2008-01-28
• Last updated: 2022-08-22
• Results posted: 2022-06-28

Locations

30 sites across 1 country: United States

Regulatory

• FDA-regulated drug study