Axelopran for Cancer
(AxeCan Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test whether axelopran, a new potential drug, can slow tumor growth and improve quality of life in patients with advanced cancers of the lung, breast, pancreas, or prostate. Researchers seek to determine if axelopran is safe for long-term use and if it can improve bowel function and reduce inflammation. Ideal participants are those whose cancer has returned or worsened after standard treatments and who currently use opioid medication daily. Participants will take axelopran pills daily and attend regular study visits, which include medical tests and surveys. As a Phase 2 trial, this research measures how well axelopran works in an initial, smaller group of people, offering participants the chance to contribute to important findings.
Do I need to stop taking my current medications to join the trial?
You may need to stop taking certain medications to join the trial. Specifically, you cannot use buprenorphine, alvimopan, naltrexone, methylnaltrexone, naloxone, lubiprostone, linaclotide, or tapentadol within 14 days before enrolling, and you must avoid certain other medications like strong CYP3A4 inhibitors and inducers. It's best to discuss your current medications with the trial team to see if any changes are needed.
Is there any evidence suggesting that axelopran is likely to be safe for humans?
Research has shown that axelopran has been tested in studies to evaluate its effectiveness with cancer treatments known as checkpoint inhibitors. These studies found that axelopran can help shrink tumors and boost the immune system. They also assessed the safety and tolerability of axelopran for patients.
Although detailed information on side effects from these studies is not available, the testing of axelopran with advanced cancer patients suggests it demonstrated some level of safety in earlier research. Generally, if a treatment reaches this testing phase, it indicates positive signs of safety and tolerability in earlier stages.
Overall, researchers are carefully monitoring axelopran to ensure its safety for patients, and any side effects will be reported and addressed as the trial progresses.12345Why do researchers think this study treatment might be promising?
Axelopran is unique because it represents a novel approach in cancer treatment with its specific mechanism of action. Unlike standard chemotherapy treatments that target rapidly dividing cells broadly, Axelopran is designed to target specific pathways involved in cancer cell survival and growth. This targeted approach may offer a more precise treatment option, potentially reducing side effects and improving effectiveness. Researchers are excited about Axelopran because it could lead to better outcomes for patients with fewer complications than traditional cancer therapies.
What evidence suggests that axelopran might be an effective treatment for advanced cancers?
Research has shown that axelopran, administered as monotherapy in this trial, may slow tumor growth and improve the quality of life for cancer patients. In animal studies, axelopran counteracted the negative effects of opioids on the immune system, which is crucial for cancer treatment. It has also been tested in various cancers, such as lung cancer, and may reduce inflammation and related symptoms. This suggests it might help manage cancer-related issues like bowel function and overall well-being. Although more data from human trials is needed, early results are promising.23678
Who Is on the Research Team?
Dylan Zylla, MD, MS
Principal Investigator
HealthPartners Institute Cancer Research Center
Are You a Good Fit for This Trial?
Adults with advanced prostate, breast, lung (NSCLC), or pancreatic cancer that has worsened after standard treatment can join. They must have a life expectancy of at least 2 months, be on opioid pain medication, and have at least one measurable tumor. Specific conditions apply for each cancer type regarding prior treatments received.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants take oral axelopran capsules daily for up to 1 year, with primary assessment at 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term treatment
Participants may continue axelopran treatment beyond 1 year if deriving benefit
What Are the Treatments Tested in This Trial?
Interventions
- Axelopran
Trial Overview
The trial is testing axelopran's effectiveness in slowing tumor growth, improving bowel function and quality of life, reducing inflammation and cachexia (wasting syndrome), and lowering certain blood markers. Participants will take axelopran daily for up to a year or more if beneficial.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
axelopran capsules administered daily as monotherapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
HealthPartners Institute
Lead Sponsor
Glycyx MOR Inc.
Industry Sponsor
Citations
Axelopran in Advanced Cancers (AxeCan)
The primary objective of this single arm, open label, phase II trial is to determine if axelopran use impacts cancer control in patients ...
Our Science | Glycyx – Advancing Cancer Treatment
Validated in Multiple Solid Tumor Models Axelopran's mechanism has been confirmed in preclinical studies across melanoma, head and neck cancer, lung cancer and ...
Axelopran for Cancer (AxeCan Trial)
The trial is testing axelopran's effectiveness in slowing tumor growth, improving bowel function and quality of life, reducing inflammation and ...
Opioids interfere with cancer immunotherapy, but another ...
When given alongside morphine, methylnaltrexone and axelopran almost completely blocked opioid-induced immunosuppression in mice, allowing anti- ...
5.
globaltrialaccelerators.com
globaltrialaccelerators.com/blog/opioids-and-immunotherapy-a-hidden-connection/Opioids and Immunotherapy: A Hidden Connection?
The ongoing Phase 2 trials for axelopran will provide valuable data on its safety and efficacy, potentially paving the way for its widespread ...
6.
file.medchemexpress.com
file.medchemexpress.com/batch_PDF/HY-16765A/Axelopran-sulfate-SDS-MedChemExpress.pdfAxelopran sulfate-SDS-MedChemExpress
Axelopran (sulfate) ... Identified uses : Laboratory chemicals, manufacture of substances. 1.3 Details of the supplier of the safety data sheet ... cancer, birth ...
Safety Data Sheet
ACCIDENTAL RELEASE MEASURES. 6.1. Personal precautions, protective equipment and emergency procedures. Avoid dust formation. Avoid breathing mist, gas or ...
Axelopran
Recent data suggests that μ-opioid antagonists have a direct effect on overall survival in patients with advanced cancer. Axelopran. Clinical data. ATC ...
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