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

NCT03307629 | Completed Phase 1 Results

• 1 other identifier: NOX66-002A
• Study Type: interventional
• Target: 25
• Locations: 3 countries
• Sites: 10

Brief 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

Cancer

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Treatment-Emergent Adverse Events Including SAEs [Safety and Tolerability] of NOX66 Combined With Radiation Therapy at Multiple Timepoints

  Safety will be assessed through reported incidence of treatment emergent adverse events (AEs), including SAEs, dose limiting toxicities, AEs leading to withdrawal, events that are greater than CTCAE Version 4.03 Grade 2 in severity. Treatment emergent AEs are those with an onset on or after the initiation of therapy. Timepoints for AE /SAE assessment are Day 2 (start of radiation therapy treatment and one day after start of NOX66 treatment), Day 6, End of treatment (Day 16), Week 6, Week 12, and Week 24.

  Day 2, Day 6, EOT (Day 16), Week 6, Week 12, and Week 24

• Assessment of Laboratory Results

  Mean change from Baseline in absolute value of safety laboratory results (haematology and biochemistry) assessed at End of Treatment (Day 16), Week 6, Week 12, and Week 24.

  From Baseline to End of Treatment (Day 16), Week 6, Week 12, and Week 24.

• Assessment of ECG Results

  Mean change from Baseline in ECG intervals (msec) which are assessed at End of treatment (Day 16), Week 12, and Week 24.

  Baseline to End of treatment (Day 16), Week 12, and Week 24.

Secondary Outcomes (7)

• Change of Target Lesions in Participants According to RECIST 1.1 Criteria

  Week 6, Week 12, and Week 24

• Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria

  Week 6, Week 12, and Week 24

• Overall Response According to RECIST 1.1 Criteria

  From enrolment up to Week 6, Week 12, and Week 24

• Change in Overall Pain Score Using the Brief Pain Inventory - Short Form (BPI-SF)

  From enrolment up to Day 16, Week 6, Week 12, and Week 24

• Change in Prostate Specific Antigen (PSA) Levels

  From enrolment up to Week 6, Week 12, and Week 24

Study Arms (2)

NOX66 + Radiation treatment (combined) in cohorts 1-3

EXPERIMENTAL

NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 treatment given to 3 cohorts of 4 patients as 1 of 3 doses, 400mg, 800mg and 1200 mg. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts.

Drug: NOX66; Radiation: Irradiation Therapy

NOX66 + Radiation treatment (combined) in cohort 4

EXPERIMENTAL

NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose will be either one of 3 doses 400mg, 800mg and 1200 mg based on interim analyses of safety data and tumour response at WEEK 6 of 3 dose cohorts of 12 total patients. The Safety Steering Committee will inform on dose for cohort expansion. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts.

Drug: NOX66; Radiation: Irradiation Therapy

Interventions

NOX66 DRUG

NOX66 delivered as rectal suppository.

NOX66 + Radiation treatment (combined) in cohort 4; NOX66 + Radiation treatment (combined) in cohorts 1-3

Irradiation Therapy RADIATION

Radiation per selected tumour lesion.

NOX66 + Radiation treatment (combined) in cohort 4; NOX66 + Radiation treatment (combined) in cohorts 1-3

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent
• ≥ 18 years of age
• Histologically confirmed prostate cancer and/or PSA of \>100 ng/mL at original diagnosis
• Metastatic disease evidenced by either CT/MRI imaging or bone scan
• Objective evidence of disease progression as defined by either:
• i. Radiographic progression of in nodal or visceral metastases and bone disease progression with 2 or more new lesions ii. Rising PSA value ≥2ng/ml in at least 3 measurements, at least 1 week apart, with castrate levels of serum testosterone.
• Eligible to receive palliative radiation therapy for management of disease
• At least one symptomatic lesion which is suitable for radiation therapy
• ECOG Performance status 0-2
• A minimum life expectancy of 24 weeks
• Adequate bone marrow, hepatic and renal function as evidenced by:
• Absolute neutrophil count (ANC) \> 1.5 x 109/L
• Platelet count \> 100 x 109/L
• Hemoglobin \> 9.0 g/dL
• Serum bilirubin \< 1.5 x ULN

You may not qualify if:

• Tumour involvement of the central nervous system
• Uncontrolled infection or systemic disease
• Clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease, angina, and cardiac arrhythmias) or myocardial infarction within the last 12 months
• Patients with a QTc \> 470 msec on screening ECG
• Concurrent systemic chemotherapy or biological therapy
• Any situation where the use of suppository therapy is contra-indicated or impractical (eg. chronic diarrhoea, colostomy, ulcerative colitis).
• Known human immunodeficiency virus (HIV) or Hepatitis B or C (active, previously treated or both)
• Any subject whose testosterone is not suppressed i.e. is \> 0.5nmols/L
• Any other reason which, in the opinion of the investigator, will preclude suitable participation in the study.

Sponsors & Collaborators

• Noxopharm Limited: lead

Study Sites (10)

Genesis Cancer Care - Newcastle

Newcastle, New South Wales, 2290, Australia

Location

Central West Cancer Care Centre - Orange Health Service

Orange, New South Wales, 2800, Australia

Location

Genesis Cancer Care Mater Hospital

Sydney, New South Wales, 2060, Australia

Location

North West Cancer Centre, Tamworth Hospital

Tamworth, New South Wales, 2340, Australia

Location

Radiation Oncology Centres Gold Coast

Gold Coast, Queensland, 4215, Australia

Location

Research Institute of Clinical Medicine

Tbilisi, 0112, Georgia

Location

TSMU The First University Clinic

Tbilisi, 0141, Georgia

Location

National Center of Urology

Tbilisi, 0144, Georgia

Location

Institute for Personalised Medicine

Tbilisi, 0186, Georgia

Location

Canterbury Urology Research Trust

Christchurch, 8013, New Zealand

Location

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Lorena Figueroa, Director clinical Operations
• Organization: Noxopharm

lorena.figueroa@noxopharm.com

+612 9144 2223

Study Officials

• Marinella Messina, PhD

  Noxopharm Limited

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 12, 2017
• Study Start: November 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: September 15, 2020
• Last Updated: July 29, 2025
• Results First Posted: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 12 months after study completion

Locations

GE (4); NZ (1); AU (5)