In:
Future Oncology, Future Medicine Ltd, Vol. 15, No. 30 ( 2019-10), p. 3427-3433
Abstract:
RRx-001 is a cysteine-directed anticancer alkylating agent with activity in a Phase II study in platinum refractory small cell lung cancer. Here, we describe the design of REPLATINUM, an open-label, Phase III trial. 120 patients with previously platinum-treated small cell lung cancer in third line will be randomized 1:1 to receive RRx-001 followed by four cycles of a platinum doublet, and then alternating cycles of RRx-001 and single agent platinum until progression versus four cycles of a platinum doublet. At radiologic progression on the platinum doublet, patients may cross over to the RRx-001 arm. Primary objective: to demonstrate superior progression-free survival in the RRx-001 population. Secondary objectives: to demonstrate superiority for overall survival and objective response rate. Clinical Trial registration: NCT03699956
Type of Medium:
Online Resource
ISSN:
1479-6694
,
1744-8301
DOI:
10.2217/fon-2019-0317
Language:
English
Publisher:
Future Medicine Ltd
Publication Date:
2019
Permalink