NOX66-002A
Primary sponsor: Noxopharm
Contracting Research Organisation: TROG
Title
NOX66 and Palliative Radiotherapy in Patients with Late-Stage Prostate Cancer – a Phase 1b Proof of Concept and Dose confirmation study.
Summary
Many people diagnosed with cancer will have radiation therapy as part of their treatment which is commonly combined with other treatments such as chemotherapy. However, once a cancer spreads such treatments can eventually stop working. This happens because cancer cells can develop the means to resist the effect of the drugs and radiation. This is known as ‘drug-resistance’ and ‘radio-resistance’. The study drug, NOX66, has been designed to overturn that resistance so that cancer cells are able to respond to radiation therapy treatment and chemotherapy treatment more effectively.
Radiation therapy as a localised treatment that mainly affects tumours in the part of the body where the radiation is directed. Radiation therapy treatment can sometimes affect tumour(s) at other sites in the body - this is known as an ‘Abscopal’ response.
The specific purpose of this research is to see whether NOX66 will make cancer cells respond more effectively to radiotherapy and if it can affect tumours that have not had local radiation treatment as part of the ‘Abscopal’ response.
NOX66-002A is an open-label Phase I study in patients with metastatic castrate-resistant prostate cancer (CRPC) who are undergoing palliative radiotherapy for pain and symptom management. This study will investigate the use of NOX66 in combination with palliative radiotherapy. Participants will have at least two lesions, one of which is measurable and one of which is suitable for radiotherapy.
The treatment course of this study will be two weeks. In the first week, participant will be treated with a combination of NOX66 and radiation therapy treatment. In the second week, participant will continue NOX66 treatment only. Participant will be followed up at Week 6, 12, 18, and 24 after treatment.
Accural target
24
Trial chairpersons
Dr Anne Capp, Genesis Cancer Care Newcastle, NSW
Trial contact
Angie Chung, TROG Cancer Research
Phone: +61 2 4014 3901
Email: angie.chung@trog.com.au
NOX66-002A@trog.com.au
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