A Trial of PledOx + FOLFOX6 Compared to Placebo + FOLFOX6 in Patients With Metastatic Colorectal Cancer
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
The present trial is designed to determine whether pre-treatment with PledOx lowers the
frequency and severity of side effects from FOLFOX6 administration in patients with
metastatic colorectal cancer.
The efficacy of PledOx will be assessed when added to FOLFOX6 chemotherapy as first line
treatment of metastatic colorectal cancer.
This study was performed in multiple parts/phases. Part 1 was an open dose-escalation study
with the doses 2, 5 and 10 micromol/kg of calmangafodipir. No study outcomes were planned for
this part. In part 2a, participants randomly received either Placebo, 2 or 10 micromol/kg of
calmangafodipir. In part 2b, participants randomly received either Placebo, 2 or 5
micromol/kg of calmangafodipir. The overall intent of the study was to compare the effect of
antioxidant agent PledOx against placebo in one of three different doses/combinations (2
micromol/kg, 5/10 micromol/kg, 2/5/10 micromol/kg vs. placebo, in the first 8 cycles of
FOLFOX6 treatment