Important Information
Please note, we need you to ….
- Read the important documents for this study
- If you are interested, look at the dates that this study is being run (cohort visit planners) and reply to our email (don’t re-register online) to let us know which cohort(s) you are available for
- We will ring you to check your suitability and provide further information about the study
- We will make you a screening appointment at NZCR Christchurch. You will need to attend at the scheduled time if you wish to take part in the study
Study Information
ONC201 has been developed for the treatment of a type of brain cancer known as glioma, a common type of tumour that can affect the brain or the spinal cord.
ONC201 is the first member of a class of anti-cancer compounds called imipridones which have been shown to have anti-cancer activity and work by stopping cancer cells from growing. ONC201 has been shown in laboratory experiments to use a new way to kill brain tumour cells but not normal cells. It is hoped that, by stopping cancer cells from growing, ONC201 may be an effective treatment for some brain cancers.
So far, ONC201 has been tested on patients with cancer. ONC201 has also been studied in 64 healthy participants in the ONC201-101 clinical trial and is currently being studied in 16 participants with normal and severe kidney function in the ONC201-104 study. These studies are being conducted at NZCR.
The purpose of part 1 of this study is to:
- Evaluate how safe and well tolerated either a single 750mg dose or two 625mg doses of ONC201 is, in healthy participants.
- To help determine the dose level and schedule for Part 2 of the ONC201-102 study
Study Candidtes
- Males & females (females must be post-menopausal or surgically sterile)
- Aged 18 – 45 years
- BMI 18 – 30 kg/m2
- Weigh more than 50kg
- Not taking any medications
What is Involved?
Study Visits: Three x3-night stays
Outpatient visits: 1 visit
Reimbursement: $6,500 (less tax)