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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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
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
Name: Marinella Messina, PhD
Affiliation: Noxopharm Limited
Role: STUDY_CHAIR