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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Barry J A
Laird
-
Barry.laird@ed.ac.uk
Dr
Paula
Daunt
+44 (0)7801551071
p.daunt@artelobio.com
More information about this study, what is involved and how to take part can be found on the study website.
Cancer patients with anorexia and weight loss
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
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 e
You may not be able to take part if:
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.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Barry J A
Laird
-
Barry.laird@ed.ac.uk
Dr
Paula
Daunt
+44 (0)7801551071
p.daunt@artelobio.com
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by Artelo Biosciences Ltd. and funded by Artelo Biosciences Ltd..
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
