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

NCT05100628 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: NOX66-004
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Metastatic Soft-tissue Sarcoma

Keywords

Doxorubicin; Dose-escalation study; Dose-expansion study; Maximum tolerated dose

Outcome Measures

Primary Outcomes (2)

• Dose Escalation: Number of Patients With Dose-limiting Toxicities (DLTs)

  Determination of the MTD of NOX66 in combination with doxorubicin. MTD is defined as the dose level at which no more than 1 patient out of 6 experiences a DLT at the end of Cycle 1.

  Cycle 1 of each dose (Cycle length is 21 days)

• Number of Patients With Adverse Events (AEs) for NOX66

  Characterization of the safety and tolerability of NOX66.

  From first study treatment with DOX66 monotherapy through study completion, approximately of 14 months and 20 days. From February 11, 2022, to May 1, 2023

Study Arms (4)

Dose-Escalation Cohort 1: NOX66 800 mg + Doxorubicin

EXPERIMENTAL

Drug: NOX66; Drug: Doxorubicin

Dose-Escalation Cohort 2: NOX66 1200 mg + Doxorubicin

EXPERIMENTAL

Drug: NOX66; Drug: Doxorubicin

Dose-Escalation Cohort 3: NOX66 1800 mg + Doxorubicin

EXPERIMENTAL

Drug: NOX66; Drug: Doxorubicin

Dose-Expansion Cohort: NOX66 + Doxorubicin

EXPERIMENTAL

Drug: NOX66; Drug: Doxorubicin

Interventions

NOX66 DRUG

NOX66 800 mg (400 mg suppository twice daily \[BID\]). Monotherapy: 7 days of NOX66 followed by 5 days washout. Combination therapy: 7 days of NOX66 followed by 14 days washout in a 21-day cycle, for up to 6 cycles.

Dose-Escalation Cohort 1: NOX66 800 mg + Doxorubicin

Doxorubicin DRUG

Doxorubicin will be given at 75 mg/m\^2 as an intravenous infusion on Day 2 of the 21-day cycle for up to 6 cycles.

Dose-Escalation Cohort 1: NOX66 800 mg + Doxorubicin; Dose-Escalation Cohort 2: NOX66 1200 mg + Doxorubicin; Dose-Escalation Cohort 3: NOX66 1800 mg + Doxorubicin; Dose-Expansion Cohort: NOX66 + Doxorubicin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Noxopharm Limited: lead

Study Sites (4)

City of Hope

Duarte, California, 91010, United States

Location

Mayo Clinic Florida - Oncology

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Site name Washington University School of Medicine in Saint Louis

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Lorena Figueroa, Director Clinical Operations
• Organization: Noxopharm

lorena.figueroa@noxopharm.com

+ 61 2 9144 2223

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: October 29, 2021
• Study Start: February 11, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 26, 2023
• Last Updated: January 6, 2025
• Results First Posted: January 6, 2025

Record last verified: 2024-11

Locations

US (4)