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Spots Global Cancer Trial Database for Safety and Tolerability of NOX66 in Combination With Palliative Radiotherapy in Patients With Late-Stage Prostate Cancer

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Trial Identification

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

Official Title: NOX66 and Palliative Radiotherapy in Patients With Late-Stage Prostate Cancer - a Phase 1b Proof of Concept and Dose Confirmation Study

Study ID: NCT03307629

Conditions

Cancer

Study Description

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.

Detailed Description: This study will investigate three escalating doses of NOX66 in combination with palliative dose of radiation therapy to establish safety profile and / or obtain efficacy signals and to determine the optimal dose for future radiation therapy combination studies. The key hypotheses to be tested in this study are: 1. That NOX66 can be safely added to palliative dose radiation therapy. 2. That NOX66 may sensitise tumours to palliative doses of radiation therapy 3. That NOX66 in combination with radiation therapy may trigger or augment an abscopal effect Participants will have a minimum of 1 symptomatic lesion amenable to radiation therapy. Radiation therapy will be delivered at a 20Gy dosage over 5 fractions. NOX66 will be taken on 13 consecutive days starting 1 day prior to radiotherapy. The response of irradiated and non-irradiated target tumour lesions will be measured by CT/MRI scan and RECIST1.1 criteria at three time points post treatment. Pain response will be evaluated using the Brief Pain Inventory-Short Form (BPI-SF) instrument at five time points post treatment. Patients will be suitable for the study as they become indicated for palliative radiation therapy for management of their cancer. This study will enrol up to 24 patients in 3 NOX66 dose level cohorts of 4 patients (n=12) and an expansion cohort of 12 patients. Dose escalation decisions will be based on patients who experience adverse events directly related to NOX66 treatment. Following the review of accumulated safety data, disease status and treatment efficacy signals at WEEK 6 for the first 12 patients, the Study Steering Committee will determine the dose at which to continue treatment for the expansion patient Cohort 4 in the study. A further 12 patients will be recruited at this dose level.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Genesis Cancer Care - Newcastle, Newcastle, New South Wales, Australia

Central West Cancer Care Centre - Orange Health Service, Orange, New South Wales, Australia

Genesis Cancer Care Mater Hospital, Sydney, New South Wales, Australia

North West Cancer Centre, Tamworth Hospital, Tamworth, New South Wales, Australia

Radiation Oncology Centres Gold Coast, Gold Coast, Queensland, Australia

Research Institute of Clinical Medicine, Tbilisi, , Georgia

TSMU The First University Clinic, Tbilisi, , Georgia

National Center of Urology, Tbilisi, , Georgia

Institute for Personalised Medicine, Tbilisi, , Georgia

Canterbury Urology Research Trust, Christchurch, , New Zealand

Contact Details

Name: Marinella Messina, PhD

Affiliation: Noxopharm Limited

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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