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Safety and Tolerability of NOX66 in Combination With Palliative Radiotherapy in Patients With Late-Stage Prostate Cancer

NCT03307629 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-07-29

Study results available
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Summary

The study is intended as a Proof of Concept and dose confirmation study. The primary objective of this study is to observe safety and tolerability of idronoxil (NOX66) in combination with radiotherapy (at palliative doses) in patients with metastatic castrate-resistant prostate cancer (CRPC) and to confirm dose in order to progress to Phase 2/3.

Conditions

Interventions

DRUG

NOX66

NOX66 delivered as rectal suppository.

RADIATION

Irradiation Therapy

Radiation per selected tumour lesion.

Sponsors & Collaborators

  • Noxopharm Limited

    lead INDUSTRY

Principal Investigators

  • Marinella Messina, PhD · Noxopharm Limited

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2019-12-01
Completion
2020-09-15

Countries

  • Australia
  • Georgia
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03307629 on ClinicalTrials.gov