Actively Recruiting
A Phase II Trial of Cancer Response Using Axelopran in Patients With Advanced Cancers on Opioids (AxeCan)
Led by HealthPartners Institute · Updated on 2026-05-05
34
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
H
HealthPartners Institute
Lead Sponsor
G
Glycyx MOR Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating axelopran, an oral capsule treatment, in patients with advanced cancers of the lung, breast, pancreas, and prostate who are currently using opioids. This phase II, single-arm, open-label trial aims to explore if axelopran can slow tumor progression, improve bowel function and quality of life, reduce inflammation and cachexia, and assess its safety and tolerability over long-term use. Participants have relapsed or progressed after standard systemic therapies. Participants will take axelopran capsules daily as monotherapy for up to one year or longer if benefiting from the treatment. The main study period for assessing impact on cancer control is through day 43 (6 weeks). They will attempt to delay starting the next line of systemic cancer therapy until after this period, with flexibility to start earlier if needed. The study involves 10 in-person visits including imaging exams, blood draws, electronic surveys, and physical assessments. During the trial, participants will attend visits lasting 1 to 2 hours each, complete patient-reported outcomes, and track daily bowel movements. Researchers will measure objective tumor response, disease control rate, circulating tumor DNA changes, bowel function, and systemic inflammation. Safety and tolerability will be monitored throughout, and the total participation may extend up to or beyond one year depending on benefit.
CONDITIONS
Brief Title
Axelopran for Advanced Cancer in Patients Receiving Opioids
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 or older at enrollment
- Confirmed advanced lung (NSCLC), breast, pancreas, or prostate cancer that has relapsed or progressed after standard chemotherapy
- Advanced stage with no planned curative therapy
- Life expectancy of at least 2 months
- Current use of opioid medication averaging 5mg oral morphine equivalents per day over the past 3 days
- At least one measurable tumor lesion per RECIST v1.1 criteria
- At least 2 weeks since last cancer therapy, with specific prior treatments required by cancer type
- Relapsed or progressed after all standard therapies, intolerant or no effective standard therapy available, or declined other standard therapy
- Willing to delay next systemic cancer therapy until day 43 for assessment
- Completed planned palliative radiation before enrollment
- Willing to report baseline and patient-reported outcomes and daily bowel movement frequency
- Negative pregnancy tests for women of childbearing potential and use of effective contraception during the study and for 90 days after
- Male participants agree to refrain from sperm donation during the study and for 90 days after
You will not qualify if you...
- Previous gastrointestinal surgery except uncomplicated appendectomy or cholecystectomy
- Active malignancy invading GI tract causing obstruction
- Active, untreated brain metastases
- History of fecal incontinence, impaction, irritable bowel syndrome, inflammatory bowel disease, intestinal obstruction, or GI/pelvic disorders affecting bowel transit
- Unable to eat, drink, or take oral medications
- Use of certain medications (e.g., buprenorphine, naltrexone) within 14 days before enrollment that cannot be stopped
- Recent use of strong CYP3A4 inhibitors or inducers, p-glycoprotein inhibitors, or anti-VEGF therapies within specified timeframes
- Clinically significant abnormal ECG or QTc >470 msec
- Unstable diseases (cardiovascular, respiratory, gastrointestinal, endocrine, hematologic, neurologic, psychiatric) affecting study assessments
- Any condition that could interfere with safety, efficacy evaluation, or protocol compliance
- Pregnant, breastfeeding women, or women of childbearing potential not using birth control
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 43 days
Participants receive axelopran capsules daily as monotherapy to assess cancer response.
Baseline visit and 1 follow-up visit at Day 43
Trial Site Locations
Total: 2 locations
1
HealthPartners Frauenshuh Cancer Research Center
Saint Louis Park, Minnesota, United States, 55426
Actively Recruiting
2
HealthPartners Cancer Center at Regions Hospital
Saint Paul, Minnesota, United States, 55101
Actively Recruiting
Research Team
J
Jordan Cowger, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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