ART27.13 phase 1/2 trial in patients with cancer anorexia/weight loss
Research type
Research Study
Full title
A Phase 1/2 Trial of the Synthetic Cannabinoid ART27.13 in Patients with Cancer Anorexia and Weight Loss
IRAS ID
278450
Contact name
Barry Laird
Contact email
Eudract number
2020-000464-27
ISRCTN Number
ISRCTN15607817
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Anorexia is defined as the lack or loss of appetite. Anorexia in cancer patients may result from the cancer and/or its treatment with radiation or chemotherapy. While not all patients with cancer will develop weight loss, it is common. Anorexia and the resulting weight loss can compromise health, often weakening the immune system and causing discomfort and dehydration. A weight loss of more than 5% of pre-cancer weight predicted poor prognosis for cancer patients and a lower response to chemotherapy. Appetite stimulants such as the synthetic cannabinoid dronabinol and the steroid dexamethasone have been used for treatment of cancer anorexia, but none have been approved by regulatory authorities for cancer anorexia.
Available data are supportive of the potential benefit of ART27.13 (a synthetic cannabinoid) in cancer patients with anorexia and weight loss.
This study will be used to assess the safety profile and to define the most effective, safe dose to be given to patients. It will also allow for an initial assessment into the activity of ART27.13 in this patient population in terms of increased lean body mass, weight gain, and improvement of anorexia.
Patients in this study will be recruited and managed either through a palliative care setting, or referred to the managing physician through their Oncologist. Stage 1 of the study will recruit up to 24 patients (up to 4 sequential cohorts of 6 patients), at ascending doses. Stage 2 will be a placebo-controlled randomised study to compare the activity of ART23.17 at the dose level selected from Stage 1, to the matching placebo.
Eligible patients will be required to attend clinic for up to 12 visits over an approximate 18 week period. The study is expected to run for approximately 3 years in total.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
20/NE/0198
Date of REC Opinion
21 Sep 2020
REC opinion
Further Information Favourable Opinion