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

Stopped early · Phase 1

Conditions studied: Metastatic Soft-tissue Sarcoma

In brief

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.

Key facts

Study ID

NCT05100628

Run by

Noxopharm Limited

People needed

9

Starts

2022-02-11

Expected to finish

2023-05-26

Last updated by the study team

2025-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients with a histologically confirmed diagnosis of metastatic or recurrent soft tissue sarcoma
• Patients for whom treatment with doxorubicin is considered to be appropriate
• Left ventricular ejection fraction ≥ 50%
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Disease that is considered measurable according to RECIST v1.1.

You may not qualify if…

• Histologically or cytologically confirmed Kaposi's sarcoma, gastrointestinal stromal tumor (GIST), extra-skeletal myxoid chondrosarcoma, epithelioid hemangioendothelioma, and desmoid tumor
• Untreated metastases to the central nervous system
• Received previous treatment with anthracyclines and anthracenediones
• Previous radiation therapy to the mediastinal or pericardial area
• A known allergy to any of the treatment components
• Patient not willing to use suppositories
• Patients with a colostomy
• Patients who have had a colectomy (total or left hemicolectomy) with re-anastomosis
• Patients for whom administration of the suppositories are likely to cause pain (e.g., inflamed hemorrhoids, fissures, or lesions of the anus or rectum)
• Patients with fecal impaction, chronic idiopathic constipation, or chronic diarrhea or alternating irritable bowel disease
• Patients with inflammatory bowel disease
• Previous treatment with an investigational agent or the non-approved use of a drug or device within 4 weeks before study entry
• Uncontrolled diabetes mellitus
• Patients who require concomitant use of strong inhibitors or inducers of CYP3A4, CYP2D6 or P- glycoprotein (P- gp)

Where it is running

• City of Hope — Duarte, California, United States
• Mayo Clinic Florida - Oncology — Jacksonville, Florida, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Site name Washington University School of Medicine in Saint Louis — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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