Trial purpose
Side effect and wellbeing
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
You may be eligible for this study if you are aged 18 or over, have advanced cancer and a life expectancy of at least 2 months.
Two-thirds of participants in this study will receive medicinal cannabis, while the other one-third will receive placebo. Both are oils taken by mouth, initially once a day, then increasing to a maximum of 3 times a day. The dose will be increased until symptoms are adequately controlled, then maintained for up to one month. After the trial period is completed, participants will be able to access medicinal cannabis via compassionate access.
All participants will provide blood samples and answer questionnaires. Researchers would also like your carer to be involved, if you have one.
It is hoped this preliminary study will provide useful information about the risks and benefits of this formulation of medicinal cannabis, and how cannabis is metabolised by the body.
Conditions
This trial is treating people with incurable advanced cancer
Eligibility
Inclusion
*Able to provide written informed consent and greater than or equal to 18 years of age.
*Willing and able to comply with all study requirements, including treatment, blood sampling and other assessments.
*Patients with incurable advanced cancer, of any histological subtype.
*Life expectancy greater than 2 months.
*ECOG 0-2
*Female patients of childbearing potential should have a negative pregnancy test within 72 hours prior to receiving the first dose of study medication and use a medically acceptable form of contraception.
Exclusion
1. Patients with recent change to systemic anticancer treatment (chemotherapy, immunotherapy, targeted therapy, hormonal therapy). The following time intervals are relative to the first day of study therapy:
• Commenced new anticancer treatment within the last 14 days
• Completed anticancer treatment <14 days ago
• Planning to receive new anticancer treatment in the next 30 days
2. Having current radiotherapy, completed radiotherapy <14 days prior to first day of study therapy, or planning to have radiotherapy in the next 30 days
3. Severe hepatic impairment, as defined by:
• aspartate aminotransferase (AST) >5 times upper limit of normal, or
• alanine aminotransferase (ALT) >5 times upper limit of normal
4. Conditions preventing adequate absorption of study drug (including difficulty swallowing medications, intestinal obstruction, inflammatory bowel condition, colitis)
5. Inadequate renal function, defined as eGFR <30ml/min (using CKD-EPI calculation)
6. Substance use disorder (ICD-10 criteria (abuse, dependence) to alcohol, opioids, benzodiazepines, or illicit stimulants
7. Current or recent use of cannabis within 30 days prior to study entry. Participants must return a negative cannabis urine test.
8. Prior clinically significant adverse reaction to cannabis or cannabinoid based medications.
9. Unwilling to avoid driving or operating machinery whilst on trial.
10. Prior hypersensitivity or intolerable adverse reaction to cannabis or cannabinoid based medications. Patients on strong CYP3A4 inducers or inhibitors, or on strong CYP2C19 inducers or inhibitors (refer to Appendix 3).
11. Psychiatric or neurodegenerative condition which in the opinion of the investigator may compromise patient safety.
12. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a highly effective and reliable means of contraception. Male participants must have been surgically sterilised or use a (double if required) barrier method of contraception.
13. Actively receiving a concurrent investigational product.
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Olivia Newton-John Cancer Research Institute
Scientific Title
A phase I/II double-blind, randomised controlled trial assessing effect of medicinal cannabis on quality of life and symptom control in advanced cancer.
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information