drugset / Trial / NCT05291286
BXQ-350 Pharmacokinetic/Pharmacodynamic Study in Cancer Patients
Phase 0
Completed
21 enrolled
Bexion Pharmaceuticals, Inc.
CTI Clinical Trial and Consulting Services · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SAPOSIN C (NON-GLYCOSYLATED) | Other / unclassified | — | Intravenous |