Phase 1 study of romidepsin plus erlotinib in advanced non-small cell lung cancer.

ABSTRACT:

Purpose

Preclinical studies demonstrated anti-tumor efficacy of the combination of the histone deacetylase (HDAC) inhibitor romidepsin plus erlotinib in non-small cell lung cancer (NSCLC) models that were insensitive to erlotinib monotherapy. We therefore studied this combination in a phase 1 clinical trial in previously treated advanced NSCLC.

Methods

Romidepsin (8 or 10mg/m(2)) was administered intravenously on days 1, 8, and 15 every 28 days in combination with erlotinib (150 mg orally daily), with romidepsin monotherapy lead-in during Cycle 1. Correlative studies included peripheral blood mononuclear cell HDAC activity and histone acetylation status, and EGFR pathway activation status in skin biopsies.

Results

A total of 17 patients were enrolled. Median number of

SUBMITTER: Gerber DE 

PROVIDER: S-EPMC5125089 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature