Preventive Treatment of Oxaliplatin Induced Peripheral Neuropathy in Metastatic Colorectal Cancer (POLAR-M)

Phase 3 Terminated 291 enrolled Egetis Therapeutics Solasia Pharma K.K. · collab

RandomizedParallel-groupTriple-blindPrevention

Summary

This study evaluates the investigational drug PledOx in the prevention of chronic chemotherapy induced peripheral neuropathy (CIPN) induced by the drug oxaliplatin.

Timeline

Start: 2018-11-07
Primary completion: 2020-08-31
Completion: 2020-08-31

Outcome

Missed primary endpoint

Stopped: “On 23 January 2020, the Sponsor announced that the United States (US) Food and Drug Administration (FDA) had issued a clinical hold in the US of the POLAR program.”

registry analysis (superiority test); PledOx (2 µmol/kg) vs Placebo; p = 0.2266; Risk Ratio (RR) 1.3842 (95% CI 0.8172 to 2.3446) NCT03654729 ↗

registry analysis (superiority test); PledOx (5 µmol/kg) vs Placebo; p = 0.7434; Risk Ratio (RR) 1.0951 (95% CI 0.6356 to 1.8870) NCT03654729 ↗

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	2 unknown	Intravenous
Subject	Calmangafodipir	Small molecule	5 unknown	Intravenous