Phase I study of folate conjugate EC145 (Vintafolide) in patients with refractory solid tumors.

ABSTRACT:

Purpose

EC145 (vintafolide), a conjugate of folic acid and the vinca alkaloid desacetylvinblastine hydrazide (DAVLBH), is a ligand for the folate receptor (FR), with activity against FR-positive tumor xenografts in vivo. This phase I study determined the maximum-tolerated dose (MTD) of EC145 administered as a bolus intravenous injection or 1-hour infusion in patients with refractory solid tumors.

Patients and methods

EC145 was administered as a bolus injection or 1-hour infusion on days 1, 3, and 5 and days 15, 17, and 19 of each 28-day cycle with dose escalation in cohorts of three to six patients until the MTD was identified. Plasma pharmacokinetics were determined on days 1 and 3 of the first cycle.

Results

The MTD of EC145 was 2.5 mg when administered as either a

SUBMITTER: Lorusso PM 

PROVIDER: S-EPMC4104289 | biostudies-literature | 2012 Nov

REPOSITORIES: biostudies-literature