Phase 1Terminated
A Study of NOX66 Plus Doxorubicin in Anthracycline-naïve, Adult Patients With Soft Tissue Sarcoma
A Dose Escalation and Dose Expansion Study of NOX66 Plus Doxorubicin in Anthracycline-naïve, Adult Patients With Soft Tissue Sarcoma - CEP-2
- Sponsor
- Noxopharm Limited (Industry)
- Enrollment
- 9 enrolled
- Conditions
- Metastatic Soft-tissue Sarcoma
- Interventions
- NOX66; NOX66; NOX66; NOX66; Doxorubicin
- Ages
- adults, older adults
- Registry
- NCT05100628
Full record on ClinicalTrials.gov
From the registry
This is a Phase I, open-label, dose-escalation and dose-expansion study of NOX66 given rectally, in cohorts of patients with metastatic soft tissue sarcoma (STS) who have not been exposed to anthracycline therapy, using a fixed dose-escalation schema every 21 days to establish the maximum tolerated dose (MTD) of the combination of NOX66 and doxorubicin.
Primary outcomes
- Dose Escalation: Number of Patients With Dose-limiting Toxicities (DLTs)
- Number of Patients With Adverse Events (AEs) for NOX66
History
Results first posted
Last registry update
Study completion
Primary completion
Started
Registered