drugset / Trial / NCT05100628
A Study of NOX66 Plus Doxorubicin in Anthracycline-naïve, Adult Patients With Soft Tissue Sarcoma
Non-randomizedSequentialOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2022-02-11
- Primary completion
- 2023-05-01
- Completion
- 2023-05-26
Outcome
Outcome not reported
Stopped (Enrollment): “Slow recruitment”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NOX66 | Small molecule | 800 mg | Rectal |
| Subject | NOX66 | Small molecule | 1200 mg | Rectal |
| Subject | NOX66 | Small molecule | 1800 mg | Rectal |
| Background | Doxorubicin | Other / unclassified | 75 mg/m2 | Intravenous |