9
Participants
Start Date
February 11, 2022
Primary Completion Date
May 1, 2023
Study Completion Date
May 26, 2023
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."
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."
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."
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.
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.
Mayo Clinic Florida - Oncology, Jacksonville
Mayo Clinic, Rochester
Site name Washington University School of Medicine in Saint Louis, St Louis
City of Hope, Duarte
Lead Sponsor
Noxopharm Limited
INDUSTRY