drugset / Trial / NCT05291286

BXQ-350 Pharmacokinetic/Pharmacodynamic Study in Cancer Patients

NCT05291286 ↗

RandomizedParallel-groupQuadruple-blindSupportive care

Summary

This study will assess pharmacokinetic (PK)/pharmacodynamic (PD) relationships and whether BXQ-350 may decrease the intensity and/or duration of chemotherapy induced peripheral neuropathy (CIPN) thereby improving quality of life (QoL) in cancer patients who have been exposed to oxaliplatin and/or taxane-based chemotherapy. This study includes two randomized, placebo controlled, blinded treatment cycles of BXQ-350/placebo, an optional open-label BXQ-350 treatment period, and an unblinded Post-Treatment Follow-up period.

Timeline

Start
2022-10-17
Primary completion
2024-12-20
Completion
2024-12-20

Drugs

EvaluationDrugModalityDoseRoute
Subject SAPOSIN C (NON-GLYCOSYLATED) Other / unclassified — Intravenous