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

  • STATUS
    Recruiting
  • End date
    Jun 1, 2024
  • participants needed
    34
  • sponsor
    Noxopharm Limited
Updated on 23 July 2022

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.

Description

The study will contain dose-escalation cohorts and dose-expansion cohorts. The study design allows an exploration of different doses of NOX66 with safety monitoring to ensure the safety of the patients.

Dose-escalation cohorts: It will include three planned Treatment Groups (800, 1200, 1800 mg daily) and patients enrolled in these groups will receive 7 days of monotherapy treatment with NOX66 followed by a 5-day washout period. Thereafter, patients will enter a combination therapy (only if no significant toxicity is observed during monotherapy). This will commence with Cycle 1, which will consist of 7 days of NOX66, and on Day 2 of the 21-day cycle, doxorubicin will be administered. Patients will continue to be treated for up to 6 x 21-day cycles of NOX66 and doxorubicin. New patients will be entered at the next dose level of NOX66, if no dose-limiting toxicities have occurred among the first 3 patients at the end of cycle 1. During the dose-escalation, MTD of the combination of NOX66 and doxorubicin will be determined.

Dose-expansion cohort: On completion of the dose-escalation cohort, patients will be enrolled into a dose-expansion at the MTD of the combination of NOX66 and doxorubicin. All patients will enter directly into 21-day combination cycles and will be given NOX66 therapy for 7 days and doxorubicin will be administered on Day 2 of each cycle. Treatment will be terminated upon disease progression, unacceptable toxicity, or a maximum of 6 cycles.

Details
Condition Metastatic Soft-tissue Sarcoma
Treatment doxorubicin, NOX66
Clinical Study IdentifierNCT05100628
SponsorNoxopharm Limited
Last Modified on23 July 2022

Eligibility

Yes No Not Sure

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)
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