Safety, pharmacokinetics, and preliminary efficacy of E6201 in patients with advanced solid tumours, including melanoma: results of a phase 1 study.

ABSTRACT:

Background

This phase 1 first-in-human study aimed to determine the maximum-tolerated dose (MTD), dose-limiting toxicities, and safety of E6201, and to establish recommended dosing in patients with advanced solid tumours, expanded to advanced melanoma.

Methods

Part A (dose escalation): sequential cohorts received E6201 intravenously (IV) over 30 min (once-weekly [qw; days (D)1 + 8 + 15 of a 28-day cycle]), starting at 20 mg/m², increasing to 720 mg/m² or the MTD. Part B (expansion): patients with BRAF-mutated or wild-type (WT) melanoma received E6201 320 mg/m² IV over 60 minutes qw (D1 + 8 + 15 of a 28-day cycle) or 160 mg/m² IV twice-weekly (D1 + 4 + 8 + 11 + 15 + 18 of a 28-day cycle; BRAF-mutated only).

Results

MTD in Par

SUBMITTER: Tibes R 

PROVIDER: S-EPMC6008465 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature