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N-{2-Tert-Butyl-1-[(4,4-Difluorocyclohexyl)Methyl]-1H-1,3-Benzodiazol-5-Yl}Ethane-1-Sulfonamide

This article discusses the clinical trials of ART27.13, a synthetic cannabinoid drug being studied for its potential to help cancer patients suffering from anorexia and weight loss. The drug, also known as N-{2-Tert-Butyl-1-[(4,4-Difluorocyclohexyl)Methyl]-1H-1,3-Benzodiazol-5-Yl}Ethane-1-Sulfonamide, is being tested in a Phase 1/2 trial to evaluate its safety and effectiveness in improving appetite, weight gain, and quality of life in cancer patients.

Table of Contents

Introduction to ART27.13

ART27.13 is a promising new medication being studied for the treatment of cancer-related anorexia and weight loss. This drug, also known by its chemical name N-{2-TERT-BUTYL-1-[(4,4-DIFLUOROCYCLOHEXYL)METHYL]-1H-1,3-BENZODIAZOL-5-YL}ETHANE-1-SULFONAMIDE, is a synthetic cannabinoid. Synthetic cannabinoids are man-made chemicals that act on the same brain cell receptors as THC (tetrahydrocannabinol), the main active ingredient in marijuana.[1]

How ART27.13 Works

As a synthetic cannabinoid, ART27.13 is designed to interact with the body’s endocannabinoid system, which plays a role in regulating appetite, metabolism, and other bodily functions. By targeting this system, ART27.13 aims to stimulate appetite and potentially reverse weight loss in cancer patients.[1]

Conditions Treated by ART27.13

ART27.13 is specifically being studied for the treatment of:

  • Cancer-related anorexia: This is a loss of appetite or desire to eat, which is common in cancer patients.
  • Cancer-related weight loss: Unintentional weight loss is a frequent and serious problem for many cancer patients.
These conditions can significantly impact a patient’s quality of life and their ability to tolerate cancer treatments.[1]

Current Clinical Trial

ART27.13 is currently being evaluated in a Phase 1/2 clinical trial. This type of trial is designed to:

  1. Assess the safety of the drug (Phase 1)
  2. Gather preliminary data on its effectiveness (Phase 2)
The main objectives of this trial are:
  • To determine the effectiveness of ART27.13 in terms of weight gain, increase in lean body mass, improvement in performance status (measured by the Karnofsky Performance Status or KPS), and reduction of anorexia.
  • To continue assessing the safety profile of ART27.13 in patients with cancer anorexia.
  • To evaluate the impact of ART27.13 on patients’ quality of life.
The trial will measure these outcomes at 4, 8, and 12 weeks of treatment.[1]

Eligibility Criteria

To participate in this clinical trial, patients must meet certain criteria. Some key inclusion criteria are:

  • Have a confirmed cancer diagnosis
  • Experience anorexia (decreased appetite or aversion to food)
  • Have documented, unintentional weight loss of more than 5% of body weight in the past 6 months
  • Be at least 18 years old
  • Have a life expectancy of at least 12 weeks
Some exclusion criteria include:
  • Primary brain tumors or symptomatic brain metastases
  • Pregnancy or breastfeeding
  • Recent major surgery
  • Certain other medical conditions that could affect appetite or weight
It’s important to note that these are just some of the criteria, and the full list is more extensive.[1]

Administration and Dosage

ART27.13 is administered orally in the form of hard capsules. The exact dosage and schedule are being studied in the clinical trial. Some patients may receive a stable dose of 650µg for 12 weeks, while others may have their dose adjusted during the trial.[1]

Potential Benefits

If successful, ART27.13 could potentially offer several benefits to cancer patients:

  • Increased appetite
  • Weight gain
  • Improved lean body mass
  • Better overall quality of life
  • Improved ability to tolerate cancer treatments
However, it’s important to remember that these potential benefits are still being studied and are not yet confirmed.[1]

Safety Considerations

As with any medication, especially one in clinical trials, there are important safety considerations:

  • Patients are advised not to drive or operate heavy machinery for at least the first 4 weeks of treatment, as ART27.13 may cause dizziness and drowsiness.
  • The drug may interact with other medications, particularly those that affect or are affected by the CYP3A4 enzyme.
  • Patients with a history of drug misuse, including recreational use of cannabinoids, are excluded from the trial.
  • Regular monitoring of various health parameters, including blood tests and heart function, is part of the trial protocol.
The trial is designed to continue assessing the safety profile of ART27.13, which means that all side effects and safety concerns will be closely monitored and evaluated.[1]

Aspect Details
Drug Name ART27.13 (N-{2-Tert-Butyl-1-[(4,4-Difluorocyclohexyl)Methyl]-1H-1,3-Benzodiazol-5-Yl}Ethane-1-Sulfonamide)
Drug Type Synthetic Cannabinoid
Administration Oral capsule
Trial Phase Phase 1/2
Target Condition Cancer-related anorexia and weight loss
Main Objectives Assess weight gain, lean body mass, performance status, and anorexia improvement
Secondary Objectives Evaluate safety profile and quality of life
Key Inclusion Criteria Cancer diagnosis, documented weight loss, life expectancy ≥12 weeks
Key Exclusion Criteria Brain tumors, pregnancy, recent major surgery, certain medications
Primary Endpoints Changes in lean body mass and anorexia symptoms
Secondary Endpoints Safety profile and quality of life assessments

FAQ

  • What is ART27.13? ART27.13 is a synthetic cannabinoid drug being studied for its potential to help cancer patients with anorexia (loss of appetite) and weight loss. It's taken as a capsule by mouth.
  • What is the main goal of the clinical trial? The main goal is to determine how well ART27.13 works in terms of weight gain, lean body mass, performance status, and improvement of anorexia at different doses over 4, 8, and 12 weeks.
  • Who can participate in this clinical trial? Participants must be at least 18 years old, have cancer with documented unintentional weight loss of more than 5% in the past 6 months, and have a life expectancy of at least 12 weeks. There are other specific criteria for inclusion and exclusion.
  • What are some of the side effects to be aware of? Known side effects of ART27.13 include dizziness and sleepiness. Participants are asked not to drive or operate heavy machinery for at least the first 4 weeks of treatment.
  • How is the effectiveness of ART27.13 measured in this trial? The effectiveness is measured by changes in lean body mass (using weight and special scans), changes in appetite (using questionnaires), and quality of life assessments. The trial also closely monitors the safety and any side effects of the drug.

Ongoing Clinical Trials on N-{2-Tert-Butyl-1-[(4,4-Difluorocyclohexyl)Methyl]-1H-1,3-Benzodiazol-5-Yl}Ethane-1-Sulfonamide

  • Study of ART27.13 for Patients with Cancer-Related Anorexia and Weight Loss

    Recruiting

    1
    Investigated drugs:
    Ireland Norway

Glossary

  • Anorexia: A loss of appetite or desire to eat, often resulting in weight loss. In cancer patients, this is not related to an eating disorder but is a side effect of the disease or treatment.
  • Cannabinoid: A type of chemical compound that acts on certain receptors in the body, potentially affecting appetite, pain sensation, mood, and memory. ART27.13 is a synthetic (man-made) version of these compounds.
  • DEXA scan: A type of X-ray that measures bone density and body composition, including lean body mass.
  • Karnofsky Performance Status (KPS): A scale used to measure a cancer patient's general well-being and activities of daily life.
  • Lean body mass: The weight of your body minus the weight of your body fat. It includes muscle, organs, and bones.
  • Phase 1/2 trial: A early stage of clinical research that tests both the safety and effectiveness of a new drug.
  • Quality of Life (QoL): A measure of an individual's well-being, including physical and mental health, relationships, and ability to function in daily life.
  • Visual Analog Scale (VAS): A measurement tool used to score the intensity or frequency of various symptoms, often used for subjective characteristics like pain or appetite.

References

  1. http://clinicaltrials.eu/trial/study-of-art27-13-for-patients-with-cancer-related-anorexia-and-weight-loss/