A Dose Escalation and Dose Expansion Study of NOX66 Plus Doxorubicin in Anthracycline-naïve, Adult Patients with Soft Tissue Sarcoma - CEP-2

Protocol No
NOXOPHARM-NOX66-004
Principal Investigator
John Charlson
Phase
I
Summary
his is a Phase I, open-label, study of NOX66 (idronoxil), given rectally in cohorts of patients with metastatic soft tissue sarcoma who have not been exposed to anthracycline therapy, using a fixed dose-escalation schema every 21 days to establish the maximum tolerated dose.
Description
To estimate the maximum tolerated dose (MTD) of NOX66 in combination with doxorubicin. To characterize the safety and tolerability of NOX66 alone and in combination with doxorubicin.
Participating Institutions
Froedtert Hospital
Status
ON HOLD