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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 months

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%

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Noxopharm LimitedLead Sponsor

5 Previous Clinical Trials

96 Total Patients Enrolled

Frequently Asked Questions

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

What are the primary aims of this research endeavor?

"The primary outcome of Noxopharm Limited's trial, which is to be assessed over a maximum period of 14 months, will evaluate the number of dose-limiting toxicities (DLTs). Secondary outcomes being studied include progression-free survival (PFS), AUC from time zero to 12 hours postdose for idronoxil and selected metabolites, as well as terminal phase half-life for these substances."

Answered by AI

How many participants are there in this survey?

"Affirmative, the information published on clinicaltrials.gov indicates that this medical study is currently recruiting people to participate in their trial. The experiment was initially posted on October 25th 2021 and has been recently revised as of October 11th 2022, with a requirement for 100 participants across two different sites."

Answered by AI

Is this investigation looking for new participants?

"Affirmative. The clinicaltrials.gov database reveals that this medical research initiative, first established on October 25th 2021, is actively seeking volunteers. About 100 individuals have to be recruited from 2 study locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of NOX66 and External Beam Radiotherapy in Patients With Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors

2021. "A Study of NOX66 and External Beam Radiotherapy in Patients With Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04957290.