A Phase 1/2 clinical trial of ART27.13 in patients with a lack or loss of appetite and weight loss due to having cancer.

Phase 1

• Conditions: Cancer anorexia and weight loss; MedDRA version: 20.0Level: LLTClassification code 10002646Term: AnorexiaSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-000464-27-GB
• Lead Sponsor: Artelo Biosciences Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-18
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 49

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:
• Absolute neutrophil count = 1.0 X 10?/L
• Platelets = 75 X 10?/L.
• Serum creatinine = 1.5 times ULN.
• Total serum bilirubin = 1.5 times ULN ( = 3.0 times ULN if patient has been diagnosed with Gilbert’s syndrome)
• 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 duration of treatments and for 6 months after last study treatment.
10. Understand and voluntarily sign and date an Informed Consent Document 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

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. History of any recreational or illicit drug use, alcohol misuse, or other drug misuse. Current illicit drug use or recreational or medicinal use of cannabinoids is also excluded.
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified