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A proof-of-concept phase 2 randomized placebo-controlled double blind multicentre clinical trial in 2 parallel groups to evaluate the efficacy and safety of E-52862 for reducing the incidence and severity of oxaliplatin-induced peripheral...

To establish the efficacy of E-52862 to reduce the incidence and the severity of OXL-induced chronic neuropathy in patients treated for colorectal cancer To explore the efficacy of E-52862 to reduce the severity and duration of OXL-induced acute neuropathy To evaluate whether E-52862 can raise the cumulative total dose of OXL than can be delivered without dose-limiting chronic neuropathy To explore the incidence of dose-reduction dose-delays and discontinuation of oxaliplatin due to symptomatic neuropathy grade 3 or 4 To explore the incidence of adverse events by severity of serious adverse events of adverse events leading to E 52862 discontinuation and of adverse events related to E-52862 by severity To assess E-52862 plasma exposure associated with the treatment

FieldValue
Modified
2020-04-01
Release Date
2018-09-13
Identifier
21afd346-33b7-4b73-8140-ada856c5cdc5
License
Public Access Level
Public