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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 Non-small Cell Lung Carcinoma After Failure In Up to Two Prior Chemotherapeutic Regimens for Advanced Disease.

Trial Profile

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 Non-small Cell Lung Carcinoma After Failure In Up to Two Prior Chemotherapeutic Regimens for Advanced Disease.

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 30 Jun 2022

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At a glance

  • Drugs Entinostat (Primary) ; Erlotinib
  • Indications Non-small cell lung cancer
  • Focus Adverse reactions; Biomarker; Therapeutic Use
  • Acronyms ENCORE-401
  • Most Recent Events

    • 02 Jun 2022 The protocol was amended to include a double-blind and a crossover phase where patients received Erlotinib and Entinostat 10 mg, according to ClinicalTrials.gov record. Accordingly, the patient number was changed from 132 to 141 and the number of treatment arms were increased from 3 to 5.
    • 02 Jun 2022 The primary endpoint Identification of Safe-dose for the Phase 2 Double-blind Phase in the Lead-in Phase was added, according to ClinicalTrials.gov record.
    • 30 Apr 2012 Results have been published in the Journal of Clinical Oncology according to a Syndax Pharmaceuticals media release.
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