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

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Noxopharm Limited
• Treatments: Doxorubicin

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)