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Anti-tumor antibiotic

NOX66 for Soft Tissue Sarcoma

Phase 1
Waitlist Available
Research Sponsored by Noxopharm Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up initial treatment until death, disease progression, or censoring (assessed up to 18 months from first combination treatment)
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new drug, NOX66, combined with a chemotherapy drug, doxorubicin, in patients with metastatic soft tissue sarcoma who haven't had certain previous treatments. The goal is to find the safest and most effective dose of NOX66. Patients will receive NOX66 alone and then in combination with doxorubicin to see how well they tolerate it.

Eligible Conditions
  • Metastatic Soft Tissue Sarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~initial treatment until death, disease progression, or censoring (assessed up to 18 months from first combination treatment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and initial treatment until death, disease progression, or censoring (assessed up to 18 months from first combination treatment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose Escalation: Number of patients with dose-limiting toxicities (DLTs)
Number of patients with adverse events (AEs) for NOX66
Number of patients with change in brain natriuretic peptide (BNP) levels from baseline
+1 more
Secondary study objectives
Change from baseline in brief pain inventory- Short Form (BPI-SF) questionnaire
Dose-Escalation (Combination) and Dose-Expansion: Plasma concentrations of idronoxil and idronoxil metabolites or doxorubicin and doxorubicinol
Dose-Escalation (Monotherapy): AUC from time 0 to end or dosing interval (τ) [AUCτ] for idronoxil and idronoxil metabolites
+16 more

Side effects data

From 2019 Phase 1 & 2 trial • 19 Patients • NCT02941523
13%
Hydrothorax
13%
Pericarditis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Monotherapy Phase, NOX66 400 mg
Monotherapy Phase, NOX66 800 mg
Combination Phase, NOX66 400 mg
Combination Phase, NOX66 800 mg

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Dose-Expansion Cohort: NOX66 + DoxorubicinExperimental Treatment2 Interventions
Group II: Dose-Escalation Cohort 3: NOX66 1800 mg + DoxorubicinExperimental Treatment2 Interventions
Group III: Dose-Escalation Cohort 2: NOX66 1200 mg + DoxorubicinExperimental Treatment2 Interventions
Group IV: Dose-Escalation Cohort 1: NOX66 800 mg + DoxorubicinExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NOX66
2017
Completed Phase 2
~90
Doxorubicin
2012
Completed Phase 3
~8030

Find a Location

Who is running the clinical trial?

Noxopharm LimitedLead Sponsor
5 Previous Clinical Trials
107 Total Patients Enrolled
~3 spots leftby Nov 2025
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