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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

Study Summary

This trial is testing a new cancer drug to see if it is safe and effective.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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%
Pericarditis
13%
Hydrothorax
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

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
~7940

Find a Location

Who is running the clinical trial?

Noxopharm LimitedLead Sponsor
5 Previous Clinical Trials
107 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has NOX66 undergone the necessary regulatory review to become FDA certified?

"Due to its Phase 1 status, with limited evidence in support of safety and efficacy, NOX66 was assessed a score of 1."

Answered by AI

Has there been any additional research involving NOX66?

"At present, 360 clinical trials dedicated to NOX66 are underway. Of these studies, 119 have reached Phase 3 and the majority of them are located in Bronx, New york. In total, 23 599 sites around the world are conducting investigations into this medication."

Answered by AI

Is this an unprecedented clinical trial?

"Currently, there are 360 ongoing studies related to NOX66 being conducted in 1941 cities and 66 countries. This drug's history dates back to 1997 when Alfacell sponsored a 300-patient trial that ultimately approved the medication for its Phase 3 stage. Subsequently, 681 trials have been completed since then."

Answered by AI

Is this research program currently enrolling participants?

"Affirmative. Per the information recorded on clinicaltrials.gov, this scientific investigation is enrolling candidates at present. The trial was first published on February 11th 2022 and subsequently updated on July 12th 2022. There are 34 slots available across 4 distinct sites."

Answered by AI

What are the key goals of this research endeavor?

"This clinical trial will be monitored for 18 months after the initiation of combination treatment, Cycle 1 Day 1. The primary outcome being evaluated is the number of patients with dose-limiting toxicities (DLTs). Secondary metrics include time to reach Cmax (Tmax) and AUC from time 0 to infinity (AUCinf) for idronoxil and its metabolites, as well as terminal elimination phase half-life (T1/2)."

Answered by AI

What medical condition is NOX66 typically prescribed to treat?

"NOX66 is traditionally employed to treat lymphoma and Hodgkin's, but it also has applications in treating carcinomas, bronchogenic tumours, neuroblastomas (NBs), and Sezary Syndrome."

Answered by AI

To what extent has participation been allowed in this clinical trial?

"Affirmative. Information on clinicaltrials.gov indicates that this medical trial is currently endeavouring to recruit participants; the study was initially posted in February 11th 2022 and most recently modified on July 12th of the same year. 34 people need to be recruited from 4 separate sites."

Answered by AI

How many sites are carrying out this clinical research?

"The trial is currently taking place in 4 different medical sites, which are positioned in Jacksonville, Saint Louis and Duarte among others. To cut down on the burden of travel for participants it's advisable to select a study centre close to you."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of NOX66 Plus Doxorubicin in Anthracycline-naïve, Adult Patients With Soft Tissue Sarcoma
2022. "A Study of NOX66 Plus Doxorubicin in Anthracycline-naïve, Adult Patients With Soft Tissue Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05100628.
~3 spots leftby Apr 2025
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