Actively Recruiting
Axelopran for Advanced Cancer in Patients Receiving Opioids
Led by HealthPartners Institute · Updated on 2026-05-05
34
Participants Needed
2
Research Sites
131 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
The primary objective of this single arm, open label, phase II trial is to determine if axelopran use impacts cancer control in patients with advanced cancers of the lung, breast, pancreas, and prostate. The primary study period for assessing the primary aim is through day 43 (6 weeks). The main questions it aims to answer are: * Does axelopran show a signal for efficacy in slowing tumor progression? * Is axelopran safe and tolerable for long-term use in this patient population? * Does axelopran show a signal for efficacy in improving bowel function and quality of life? * Does axelopran show a signal for efficacy in reducing systemic inflammation, cachexia, and prognostic serum biomarkers of inflammation? Patients will take axelopran as monotherapy after relapse or progression on or after standard systemic therapy. Clinician and patient must be willing to attempt a delay in next line of systemic cancer therapy (if available) until day 43 to assess change in cancer status on repeat imaging. Clinician can move to the next line of therapy whenever deemed clinically necessary. Participants will: * take oral axelopran capsules daily for up to 1 year, or longer if deriving benefit * attend 10 in-person study visits, each lasting approximately 1-2 hours * complete study procedures including but not limited to imaging exams, blood draws, electronic health surveys, and physical assessments
CONDITIONS
Official Title
Axelopran for Advanced Cancer in Patients Receiving Opioids
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 or older
- Confirmed advanced prostate, breast, pancreas, or non-small cell lung cancer that has relapsed or progressed after standard systemic treatment including chemotherapy
- Cancer is locally advanced or metastatic with no plans for curative therapy
- Life expectancy of at least 2 months at screening
- Currently using opioid medication averaging at least 5 mg morphine equivalent per day over the past 3 days
- At least one measurable tumor lesion meeting RECIST v1.1 criteria
- At least 2 weeks since last cancer-directed therapy, with specific prior treatments depending on cancer type
- Relapsed or progressed after all standard therapies, intolerant to standard therapy, no effective standard therapy available, or declined standard therapy
- Willing to delay next systemic cancer therapy until day 43 for tumor assessment
- Planned palliative radiation completed before enrollment
- Willing to report baseline and required patient-reported outcomes including daily bowel movement frequency
- For women of childbearing potential, negative pregnancy tests at screening and day 1
- Sexually active participants must use highly effective contraception during the study and for 90 days after
- Males must refrain from sperm donation during the study and for 90 days after
You will not qualify if you...
- Prior gastrointestinal surgery except uncomplicated appendectomy or cholecystectomy
- Active cancer causing direct invasion or metastasis to the gastrointestinal tract
- Untreated active brain metastases
- History of fecal incontinence, impaction, irritable bowel syndrome, inflammatory bowel disease, intestinal obstruction, or other bowel disorders affecting function
- Unable to take or keep down oral medications
- Use of certain medications affecting opioid or gastrointestinal function within 14 days before enrollment
- Use of strong CYP3A4 inhibitors or inducers or P-glycoprotein inhibitors within 14 days before study drug
- Use of anti-VEGF therapy within 30 days before study drug
- Abnormal ECG or QTc interval >470 msec deemed clinically significant
- Unstable cardiovascular, respiratory, gastrointestinal, endocrine, hematologic, neurologic, psychiatric, or other significant diseases
- Any condition interfering with study compliance or evaluation
- Pregnant, breastfeeding, or women of childbearing potential not using birth control
AI-Screening
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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
CONTACT
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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