Axelopran for Cancer

(AxeCan Trial)

Not yet recruiting at 1 trial location
JC
Overseen ByJordan Cowger, MPH
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: HealthPartners Institute
Must be taking: Opioids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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.12345

Why 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?

DZ

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

My cancer has worsened after standard treatment including chemotherapy.
My cancer is advanced and there are no plans for a cure.
My doctor expects me to live at least 2 more months.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take oral axelopran capsules daily for up to 1 year, with primary assessment at 6 weeks

6 weeks
10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: Axelopran monotherapyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

HealthPartners Institute

Lead Sponsor

Trials
196
Recruited
3,721,000+

Glycyx MOR Inc.

Industry Sponsor

Citations

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Axelopran for Cancer (AxeCan Trial)

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Safety Data Sheet

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Axelopran

Recent data suggests that μ-opioid antagonists have a direct effect on overall survival in patients with advanced cancer. Axelopran. Clinical data. ATC ...