Preventive Treatment of OxaLiplatin Induced peripherAl neuRopathy in Adjuvant Colorectal Cancer

Phase 3 Terminated 301 enrolled Egetis Therapeutics Solasia Pharma K.K. · collab

RandomizedParallel-groupTriple-blindPrevention

Summary

This study is to evaluate PledOx for prevention of chronic chemotherapy induced peripheral neuropathy induced by oxaliplatin in patients with Stage III or high-risk Stage II colorectal cancer (CRC).

Timeline

Start: 2019-01-07
Primary completion: 2020-08-31
Completion: 2020-08-31

Outcome

Missed primary endpoint

Stopped (Enrollment): “On 01 March 2020, the Sponsor decided to place recruitment and dosing of patients on hold following interactions with the French regulatory authority, ANSM and the US clinical hold of another study (POLAR-M).”

paper The POLAR clinical studies failed to meet their primary endpoint. PMID 36308441 ↗

Publications

Pfeiffer P, Lustberg M, Nasstrom J, Carlsson S, Persson A, Nagahama F, Cavaletti G, Glimelius B, Muro K. Calmangafodipir for Prevention of Oxaliplatin-Induced Peripheral Neuropathy: Two Placebo-Controlled, Randomized Phase 3 Studies (POLAR-A/POLAR-M). JNCI Cancer Spectr. 2022 Nov 1;6(6):pkac075. doi: 10.1093/jncics/pkac075.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Calmangafodipir	Small molecule	5 unknown	Intravenous