A trial of the synthetic cannabinoid ART27.13 to stimulate appetite in patients with cancer anorexia and weight loss
| ISRCTN | ISRCTN15607817 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15607817 |
| EudraCT/CTIS number | 2020-000464-27 |
| IRAS number | 278450 |
| ClinicalTrials.gov number | Nil Known |
| Secondary identifying numbers | ART27.13-100, IRAS 278450 |
- Submission date
- 06/04/2021
- Registration date
- 09/04/2021
- Last edited
- 08/07/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
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. It is common for patients with cancer to lose weight. Anorexia and the resulting weight loss can affect a patient’s health, often weakening their immune system and causing discomfort and dehydration. A weight loss of more than 5% can predicted a poor outcome for cancer patients and a lower response to chemotherapy. Drugs that increase a patient’s appetite (appetite stimulants) have been used for treatment of cancer anorexia, but none have been approved for this use.
Anorexia is an issue for many patients with cancer, and ART27.13 may increase appetite, lean body mass, and weight in these patients.
This study will assess the safety of ART27.13 and determine the most effective, safe dose to be given to patients. The study will also assess the activity of ART27.13 in cancer patients with anorexia and weight loss by measuring increased lean body mass, weight gain, and improvement of anorexia.
Who can participate?
Male and female patients over the age of 18 with certain types of cancer who are either not on anticancer therapy or are on a stable daily doses of certain treatments and have documented weight loss of >5% of their body weight in the past 6 months.
What does the study involve?
Patients who agree to participate in the study, will be asked to sign the study Informed Consent Form. Involvement in the study will take a maximum of 18 weeks in total, during which patients will be required to attend a number of clinic visits to undergo a series of assessments. The following assessments will be performed (please note, not all assessments are performed at every visit):
- General medical and physical examinations, including height and weight measurement
- A pregnancy test
- Vital signs (assessment of heart rate, breathing rate, blood pressure and body temperature)
- An electrocardiogram (also known as an ‘ECG’)
- Blood samples, for routine safety tests, for checking levels of the study drug in the body and for checking of levels of certain components of the blood which may indicate a response to the drug.
- A DEXA scan, which is a type of x-ray used to measure the amount of lean body mass (muscle)
- A series of questionnaires which aim to assess patients' symptoms of anorexia and quality of life
- Complete a diary for any steroids taken
What are the possible benefits and risks of participating?
It is not known whether there will be any benefit for the patients in this study. However, there is data to suggest that ART27.13 may help increase appetite, and thereby lead to patients maintaining (not losing) and even gaining weight.
Where is the study run from?
The CAReS study will be run at the following hospitals in the United Kingdom and Ireland:
- Western General Hospital, Edinburgh
- The Royal Marsden NHS Foundation Trust, London (Sutton and Chelsea)
- Hammersmith Hospital, London
- St James's Hospital, Leeds
- The Christie Hospital, Manchester
- St James's Hospital, Dublin
- Royal Derby Hospital, Derby
-The VCTC, Castle Donington, Oxford and Wellingborough
-University Hospital, Hairmyers, Glasgow
When is the study starting and how long is it expected to run for?
February 2020 to October 2025
Who is funding the study?
The study is funded by Artelo Biosciences Ltd. (UK)
Who is the main contact?
Dr Barry JA Laird, Barry.laird@ed.ac.uk
Dr Paula Daunt, p.daunt@artelobio.com
Contact information
Public
Institute of Genetics and Cancer
University of Edinburgh
Edinburgh
EH4 2XU
United Kingdom
 ORCID ID |
0000-0002-2807-6192 |
|---|---|
| Barry.laird@ed.ac.uk |
Public
Artelo Biosciences Ltd.
Mereside
Alderley Park
Alderley Edge
SK10 4TG
United Kingdom
| Phone | +44 (0)7801551071 |
|---|---|
| p.daunt@artelobio.com |
Study information
| Study design | Open-label multicenter dose-escalation study followed by a randomized double-blind placebo-controlled multicenter study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format. Please use contact details to request a participant information sheet. |
| Scientific title | Cancer Appetite Recovery Study (CAReS): a phase 1/2 trial of the synthetic cannabinoid ART27.13 in patients with cancer anorexia and weight loss |
| Study acronym | CAReS |
| Study objectives | The drug ART27.13 is safe and can be utilized to improve the symptoms of anorexia in patients with cancer. |
| Ethics approval(s) | Approved 21/09/2020, North East – Tyne & Wear South Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)207 104 8084; tyneandwearsouth.rec@hra.nhs.uk), ref: 20/NE/0198 |
| Health condition(s) or problem(s) studied | Cancer patients with anorexia and weight loss |
| Intervention | Current interventions as of 28/11/2023: ART27.13 (or the matching placebo in Stage 2) is orally administered to patients once daily for up to 12 weeks. Stage 1 (12 weeks) assesses ART27.13 in escalating doses of 150, 250, 400, and possibly 650 µg/day. In Stage 2 (12 weeks), patients are randomized in a 3:1 ratio to ART27.13 or matching placebo. The randomization schedule is kept at the Pharmacy at each site. _____ Previous interventions: ART27.13 (or the matching placebo in Stage 2) is orally administered to patients once daily for up to 12 weeks. Stage 1 (12 weeks) assesses ART27.13 in escalating doses of 150, 250, 400, and possibly 650 µg/day. In Stage 2 (12 weeks), patients are randomized in a 4:1 ratio to ART27.13 or matching placebo. The randomization schedule is kept at the Pharmacy at each site. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase I/II |
| Drug / device / biological / vaccine name(s) | ART27.13 |
| Primary outcome measure | Stage 1: Safety is evaluated by the assessment of the type, frequency and severity of adverse drug effects throughout the 12 week treatment period and the 30-day follow up period and routine chemistry, haematology, urinalysis, vital signs and ECGs at baseline, weekly for 4 weeks, bi-weekly for 8 weeks and at the 30 day follow up period. Stage 2: the change in lean body mass is determined by weight and dual-energy X-ray absorptiometry (DEXA) body scans at 12 weeks, and the change in anorexia is determined by visual analogue scale (VAS) at baseline, week 4, week 8, week 12 and at the 30-day follow up visit |
| Secondary outcome measures | Stage 1: 1. The change in lean body mass is determined by weight and DEXA scans at 12 weeks 2. The change in anorexia is determined by VAS and Functional Assessment of Anorexia and Cachexia Therapy (FAACT) questionnaire at baseline, week 2 (FAACT only), week 4, week 8, week 12 and at the 30-day follow up visit 3. The change in performance status as per the Karnofsky Performance Status (KPS) is determined at baseline, weekly for the first 4 weeks, then once every 4 weeks for the remaining 8 weeks of treatment, and at the 30-day follow up visit. 4. Quality of life (QoL) is measured using the FAACT questionnaire, the patient-generated subjective global assessment (PG-SGA), the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C15-PAL and revised Edmonton Symptom Assessment Scale (r-ESAS) questionnaires at baseline, 2 weeks, 4 weeks and 8 weeks and at the 30-day follow-up. 5. The pharmacokinetics of ART27.13 is determined by analyzing blood concentrations of ART27.13 in samples taken at baseline, at 1, 2, 4, 6 and 24 hours post dosing on the first day of dosing (cycle 1 day 1), and again after 4 weeks (cycle 2 day 1) and 8 weeks (cycle 3 day 1). Stage 2: 1. Safety is evaluated by the assessment of the type, frequency and severity of adverse drug effects throughout the 12 week treatment period and the 30-day follow up period and routine chemistry, hematology, urinalysis, vital signs and ECGs at baseline, weekly for 4 weeks, bi-weekly for 8 weeks and at the 30 day follow up period. 2. QoL is measured using the FAACT, PG-SGA, EORTC QLQ-C15-PAL and r-ESAS questionnaires at baseline, 2 weeks, 4 weeks, 8 weeks and at the 30-day follow-up. |
| Overall study start date | 01/02/2020 |
| Completion date | 30/10/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 64 |
| Key inclusion criteria | Current inclusion criteria as of 28/11/2023: 1. Have cancer (except those excluded by the exclusion criteria) documented by histopathology or cytology. 2. Have anorexia as determined by self-reported decrease or lack of appetite or aversion to food. 3. Have documented, unintentional weight loss of >5% of body weight in the past 6 months dating back from the date of enrollment. 4. Patients are on either: 4.1 no anti-cancer therapy for the 2 weeks before enrollment and are not expected to have anti-cancer therapy for the first 12 weeks after the first dose of ART27.13 (Stage 1) or if in Stage 2, after the start of ART27.13/placebo; or 4.2 stable daily dosing from 2 weeks before enrolment and expected to be on such therapy for another 12 weeks of anti-cancer monotherapy therapy with hormonal therapy for breast, prostate, or uterine cancer or capecitabine for breast or colon cancer. 5. Estimated life expectancy of at least 12 weeks as judged by the Investigator based on clinical impression. 6. Have a KPS of >50. 7. At least 18 years of age at the time of enrollment. 8. Adequate hematological, renal, and hepatic function based on laboratory values obtained within 14 days of randomization: 8.1. Absolute neutrophil count ≥ 1.0 X 109/L 8.2. Platelets ≥75 x 10^9/L 8.3. Serum creatinine ≤ 1.5 times upper limit of laboratory normal (ULN) 8.4. Total serum bilirubin ≤ 1.5 times ULN (≤ 3.0 times ULN if patient has been diagnosed with Gilbert’s syndrome) 8.5. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (AP) ≤ 2.5 times ULN 9. For women of child-bearing potential and for men with partners of child-bearing potential, patient must agree to take contraceptive measures for the duration of treatments and for 6 months after the last study treatment. 10. Understand and voluntarily sign and date an Informed Consent Document ICD prior to any study related assessments/procedures. 11. Willing and able to adhere to the study visit schedule and other protocol requirements. 12. Agree to not driving or operating heavy machinery for the first 4 weeks of treatment or longer if adverse events warrant as known adverse events of ART27.13 include dizziness and somnolence. _____ Previous inclusion criteria: 1. Have cancer (except those excluded by the exclusion criteria) documented by histopathology or cytology. 2. Have anorexia as determined by self-reported decrease or lack of appetite or aversion to food. 3. Have documented, unintentional weight loss of >5% of body weight in the past 6 months dating back from the date of enrollment. 4. Patients are on either: 4.1 no anti-cancer therapy for the 2 weeks before enrollment and are not expected to have anti-cancer therapy for the first 12 weeks after the first dose of ART27.13 (Stage 1) or if in Stage 2, after the start of ART27.13/placebo; or 4.2 stable daily dosing from 2 weeks before enrolment and expected to be on such therapy for another 12 weeks of anti-cancer monotherapy therapy with hormonal therapy for breast, prostate, or uterine cancer or capecitabine for breast or colon cancer. 5. Estimated life expectancy of at least 12 weeks as judged by the Investigator based on clinical impression. 6. Have a KPS of >50. 7. At least 18 years of age at the time of enrollment. 8. Adequate hematological, renal, and hepatic function based on laboratory values obtained within 14 days of randomization: 8.1. Absolute neutrophil count ≥ 1.0 X 109/L 8.2. Platelets ≥75 x 10^9/L 8.3. Serum creatinine ≤ 1.5 times upper limit of laboratory normal (ULN) 8.4. Total serum bilirubin ≤ 1.5 times ULN (≤ 3.0 times ULN if patient has been diagnosed with Gilbert’s syndrome) 8.5. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (AP) ≤ 2.5 times ULN 9. For women of child-bearing potential and for men with partners of child-bearing potential, patient must agree to take contraceptive measures for the duration of treatments and for 6 months after the last study treatment. 10. Understand and voluntarily sign and date an Informed Consent Document ICD prior to any study related assessments/procedures. 11. Willing and able to adhere to the study visit schedule and other protocol requirements. 12. Willing to avoid sun exposure by using protective measures such as sunscreen, clothing, and sunglasses during therapy because the phototoxicity of ART27.13 has not been studied in animals. 13. Agree to not driving or operating heavy machinery for the first 4 weeks of treatment or longer if adverse events warrant as known adverse events of ART27.13 include dizziness and somnolence. |
| Key exclusion criteria | 1. Primary brain tumors or symptomatic brain metastases. 2. Unable to swallow food or medication capsules. 3. Patients with oral mucositis or oral fungal infection causing anorexia or impairing taste. 4. Have a disorder that causes obstruction of the gastrointestinal tract or limits the absorption of calories such as bowel obstruction or celiac disease. 5. Receiving tube feedings or parenteral nutrition. 6. Be on, been on within 4 weeks prior to enrollment, or expected to be on medications that have the potential to affect anorexia or caloric intake. Examples of such medications include any synthetic or natural cannabinoid (inhaled or administered by any other route) and megestrol. 7. Corticosteroids are allowed if on a stable or tapering dose for 2 weeks prior to enrollment. Patients taking inhaled corticosteroids are permitted. 8. Current illicit drug use or recreational or medicinal use of cannabinoids. 9. Known hypersensitivity to ART27.13 or any of its excipients. A list of ingredients of ART27.13 capsules will be provided to sites prior to the start of Stage 1 of the protocol. Prior to the start of Stage 2, the list of ingredients will be provided for placebo. 10. Pregnant or breast feeding. 11. Clinically significant depression requiring current use of antidepressant medications. 12. Condition other than cancer that could cause anorexia and/or weight loss such as AIDS, chronic obstructive pulmonary disease, chronic kidney disease, heart failure, or pathological eating disorder. 13. Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection requiring intravenous (IV) antibiotics & psychiatric illness/social situations that would limit compliance with study requirements. 14. Major surgery within 2 weeks prior to enrollment. 15. Any comorbid condition that confounds the ability to interpret data from the study as judged by the Investigator or Medical Monitor. 16. Known human immunodeficiency virus infection, acute or chronic hepatitis B, or acute hepatitis C infection. 17. Clinically significant ascites requiring or expected to require paracentesis. 18. Corrected QT intervals (QTc) intervals calculated according to Fridericia’s formula (QTcF) >480 ms. 19. Anticipated need for anti-cancer therapy from 2 weeks prior to enrollment and 12 weeks after the first dose of ART27.13 or in Stage 2 ART27.13/placebo. (Continued use of current daily-dose anti-cancer therapy is allowed.) 20. Investigational agent within 4 weeks prior to enrollment or expected need for an investigational agent for 12 weeks after the first dose of ART27.13 or in Stage 2 placebo. 21. Receiving radiotherapy within 2 weeks dating back from enrollment or anticipated to need radiotherapy within 12 weeks of enrollment. Short term palliative radiation treatment involving a local lesion is allowed. |
| Date of first enrolment | 23/03/2021 |
| Date of final enrolment | 30/08/2025 |
Locations
Countries of recruitment
- England
- Ireland
- Scotland
- United Kingdom
Study participating centres
Edinburgh
EH4 2XU
United Kingdom
London
SW3 6JJ
United Kingdom
Sutton
SM2 5PT
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
Withington
Manchester
M20 4BX
United Kingdom
Dublin
DO8 NHY1
Ireland
Market Street
Castle Donington
DE74 2JB
United Kingdom
Little Baldon
Oxford
OX44 9PU
United Kingdom
3 Queen Street
Wellingborough
NN8 4RW
United Kingdom
East Kilbride
G75 8RG
United Kingdom
Sponsor information
Industry
Mereside
Alderley Park
Alderley Edge
SK10 4TG
United Kingdom
| info@artelobio.com | |
| Website | https://artelobio.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The sponsor intends to make available the results of the study using one or more of the following methods: 1. Publication in one or more peer-reviewed scientific journal. 2. Conference presentation 3. Publication on company website artelobio.com |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
08/07/2025: The following changes were made to the trial record:
1. The date of final enrolment was changed from 30/04/2025 to 30/08/2025.
2. The completion date was changed from 30/07/2025 to 30/10/2025.
3. The plain English summary was updated to reflect these changes.
01/04/2025: The recruitment end date was changed from 30/03/2025 to 30/04/2025.
07/01/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 30/12/2024 to 30/03/2025.
2. The overall study end date was changed from 30/03/2025 to 30/07/2025.
3. The intention to publish date was changed from 30/06/2025 to 30/10/2025.
4. The study participating centres were updated to remove Hammersmith Hospital and add The VCTC, Castle Donington, Oxford and Wellingborough and University Hospital Hairmyres.
02/12/2024: The recruitment end date was changed from 30/11/2024 to 30/12/2024.
28/11/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2023 to 30/11/2024.
2. The overall end date was changed from 31/01/2024 to 30/03/2025.
3. The intention to publish date was changed from 30/04/2024 to 30/06/2025.
4. The interventions were changed.
5. The inclusion criteria were changed.
6. The target number of participants was changed from 49 to 64.
7. The plain English summary was updated to reflect these changes.
10/03/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 28/02/2023 to 30/09/2023.
2. The overall end date was changed from 30/06/2023 to 31/01/2024.
3. The intention to publish date was changed from 30/09/2023 to 30/04/2024.
4. The plain English summary was updated to reflect these changes.
29/07/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2022 to 28/02/2023.
2. The overall end date was changed from 30/10/2022 to 30/06/2023.
3. The intention to publish date was changed from 31/01/2023 to 30/09/2023.
4. The plain English summary was updated to reflect these changes.
08/06/2022: The following changes were made to the trial record:
1. The contact was updated.
2. The plain English summary was updated to reflect these changes.
17/05/2022: The following changes have been made:
1. Trial website added.
2. Ireland was added to the countries of recruitment.
3. The Royal Marsden Hospital (London), The Royal Marsden Hospital (Surrey), Hammersmith Hospital, St James's University Hospital, The Christie, and St James Hospital were added to the trial participating centres.
29/12/2021: The following changes have been made:
1. The recruitment end date has been changed from31/12/2021 to 30/06/2022.
2. The overall trial end date has been changed from 01/04/2022 to 30/10/2022 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from 01/07/2022 to 31/01/2023.
08/04/2021: Trial's existence confirmed by North East – Tyne & Wear South Research Ethics Committee
