drugset / Trial / NCT04150042

SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells

NCT04150042

NaSingle-groupOpen-labelTreatment

Summary

The clinical trial is a phase 1, single-arm trial that will evaluate the safety of the investigational treatment on metastatic pancreatic cancer and metastatic breast cancer. The investigational treatment will involve 2 cycles of a combination of intravenous melphalan, BCNU, vitamin B12b, and vitamin C with autologous hematopoietic stem cell infusion. A dose-escalation schedule is being employed for the vitamin C.

Timeline

Start
2021-01-13
Primary completion
2028-12
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Subject AQUACOBALAMIN Unknown Intravenous
Subject Melphalan Small molecule Intravenous
Subject Vitamin C Other / unclassified Intravenous
Subject carmustine Small molecule Intravenous