A Study of NOX66 Plus Doxorubicin in Anthracycline-naïve, Adult Patients With Soft Tissue Sarcoma

PHASE1TerminatedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

February 11, 2022

Primary Completion Date

May 1, 2023

Study Completion Date

May 26, 2023

Conditions
Metastatic Soft-tissue Sarcoma
Interventions
DRUG

NOX66

"NOX66 800 mg (400 mg suppository twice daily \[BID\]).~Monotherapy: 7 days of NOX66 followed by 5 days washout. Combination therapy: 7 days of NOX66 followed by 14 days washout in a 21-day cycle, for up to 6 cycles."

DRUG

NOX66

"NOX66 1200 mg daily (600 mg suppository BID).~Monotherapy: 7 days of NOX66 followed by 5 days washout. Combination therapy: 7 days of NOX66 followed by 14 days washout in a 21-day cycle, for up to 6 cycles."

DRUG

NOX66

"NOX66 1800 mg daily (600 mg suppository thrice daily).~Monotherapy: 7 days of NOX66 followed by 5 days washout. Combination therapy: 7 days of NOX66 followed by 14 days washout in a 21-day cycle, for up to 6 cycles."

DRUG

NOX66

MTD of the combination of NOX66 and doxorubicin will be determined in the dose-escalation cohort of the study. The selected dose will be administered in combination with Doxorubicin.

DRUG

Doxorubicin

Doxorubicin will be given at 75 mg/m\^2 as an intravenous infusion on Day 2 of the 21-day cycle for up to 6 cycles.

Trial Locations (4)

32224

Mayo Clinic Florida - Oncology, Jacksonville

55905

Mayo Clinic, Rochester

63110

Site name Washington University School of Medicine in Saint Louis, St Louis

91010

City of Hope, Duarte

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Noxopharm Limited

INDUSTRY