Idronoxil Suppository Combine With Radiotherapy for Metastatic Prostate Cancer

NCT03041285 | Terminated Phase 1 DMC

• 1 other identifier: NOX66 version 1
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to determine the toxicity of Idronoxil (NOX66) when used in combination with palliative radiotherapy for metastatic prostate cancer

Conditions

Metastatic Castrate- Resistant Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• safety of Idronoxil dose escalation

  Toxicity and relationship with study drug NOX66 will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V4.3

  From start of NOX66 with stereotactic radiotherapy up to three months post treatment.

Secondary Outcomes (1)

• evidence of clinical tumour response

  3 months post treatment

Study Arms (2)

Group 1 NOX66 400mg and SBRT

EXPERIMENTAL

Group 1 patients will receive 400mg of Idronoxil (NOX66) suppository (1 suppository) daily from Day 0 (1 day before radiotherapy) until 7 days after completion of radiotherapy. Stereotactic Body Radiation Therapy will be given on Days1-5 (5 fractions). Total treatment course is 13-15 days, depends on whether radiotherapy is given on consecutive days or over the weekend.

Drug: idronoxil (NOX66) suppository; Radiation: Stereotactic Body Radiation Therapy

Group 2 NOX66 800mg and SBRT

EXPERIMENTAL

Group 2 patients will receive 800mg of Idronoxil (NOX66) suppository (2 suppositories) daily from Day 0 (1 day before radiotherapy) until 7 days after completion of radiotherapy. Stereotactic Body Radiation Therapy will be given on Days1-5 (5 fractions). Total treatment course is 13-15 days, depends on whether radiotherapy is given on consecutive days or over the weekend.

Drug: idronoxil (NOX66) suppository; Radiation: Stereotactic Body Radiation Therapy

Interventions

idronoxil (NOX66) suppository DRUG

Patients in Group 1 will be given 400mg of Idronoxil suppository (NOX66) (1 suppository) daily from Day 0(1 day before radiotherapy) until 7 days after radiotherapy. Group 2 will be given Idronoxil (NOX66) 800mg (2 suppositories) daily from Day 0 until 7 days after radiotherapy. All patients will receive one course of Stereotactic Body Radiation Therapy (SBRT), to be delivered in 20 Gray in 5 fractions. Radiotherapy session will involve irradiation of 1-2 lesions. .

Also known as: NOX66

Group 1 NOX66 400mg and SBRT; Group 2 NOX66 800mg and SBRT

Stereotactic Body Radiation Therapy RADIATION

All patients (Group 1 and Group 2) will receive one course of Stereotactic Body Radiation Therapy (SBRT), to be delivered in 20 Gray in 5 daily fractions on consecutive days. Radiotherapy session (week 1) will involve irradiation to 1-2 lesions.

Group 1 NOX66 400mg and SBRT; Group 2 NOX66 800mg and SBRT

Eligibility Criteria

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

You may qualify if:

• Confirmed metastatic prostate cancer that is castrate-resistant.
• lesions suitable for radiotherapy.
• ECOG Performance status 0-2.
• Adequate bone marrow, hepatic and renal function
• At least 4 weeks must have elapsed prior to commencement of idronoxil treatment since prior chemotherapy, investigational drug or biologic therapy

You may not qualify if:

• Chemotherapy regimens with delayed toxicity within the last 4 weeks.
• Any situation where the use of suppository therapy is contra-indicated or impractical(eg. chronic diarrhoea, colostomy, ulcerative colitis).
• No concurrent systemic chemotherapy or biologic therapy is allowed.
• Psychiatric disorder or social or geographic situation that would preclude study participation.
• Patient unable to provide consent

Sponsors & Collaborators

• Royal North Shore Hospital: lead

Study Sites (1)

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

MeSH Terms

Interventions

phenoxodiol; Suppositories; Radiosurgery

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Thomas Eade

  Northern Sydney Local Health District

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: There is no masking.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Group 1 (6 participants) will receive 400mg of Idronoxil (NOX66) daily in the form of one suppository. Group 2 (6 participants) will receive 800mg of Idronoxil daily (two suppositories). Group 2 will only commence once all group 1 participants have completed their treatment course and have experienced no toxicity greater than grade 2 according CTCAE version 4.03 for adverse events assessment.

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: February 2, 2017
• Study Start: August 31, 2017
• Primary Completion: September 17, 2019
• Study Completion: September 17, 2019
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)