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NOX66 for Prostate Cancer

Phase 1 & 2
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 up to 30 months
Awards & highlights

Study Summary

This trial is testing a new drug, idronoxil, to see if it is safe and effective when given rectally as a suppository to patients with various types of cancer. The trial will also look at the drug's pharmacokinetics (how the body processes the drug) and pharmacodynamics (how the drug affects the body).

Eligible Conditions
  • Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1 (Dose Escalation): Number of dose-limiting toxicities (DLTs)
Part 2 (Dose Expansion): Arm 1 (mCRPC only): Number of patients with change from Baseline in prostate-specific antigen (PSA) at the end of Cycles 3 and 6
Secondary outcome measures
AUC from time zero (predose) extrapolated to infinity (AUC(0-inf)) for idronoxil and selected metabolites
AUC from time zero (predose) to 12 hours postdose (AUC(0-12)) for idronoxil and selected metabolites
AUC from time zero (predose) to 6 hours postdose (AUC(0-6)) for idronoxil and selected metabolites
+22 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

6Treatment groups
Experimental Treatment
Group I: Part 2: Arm 2: Patients with BC or NSCLC (RP2D NOX66)Experimental Treatment2 Interventions
Group II: Part 2: Arm 1: Patients with mCRPC (RP2D NOX66)Experimental Treatment2 Interventions
Group III: Part 1: Dose Cohort 4: NOX66 2400 mgExperimental Treatment2 Interventions
Group IV: Part 1: Dose Cohort 3: NOX66 1600 mgExperimental Treatment2 Interventions
Group V: Part 1: Dose Cohort 2: NOX66 1200 mgExperimental Treatment2 Interventions
Group VI: Part 1: Dose Cohort 1: NOX66 800 mgExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NOX66
2017
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

Noxopharm LimitedLead Sponsor
5 Previous Clinical Trials
96 Total Patients Enrolled
~6 spots leftby Jun 2025
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