Breast CancerPhase 2AxeCanNCT07354919
Axelopran for Advanced Cancer in Patients Receiving Opioids
A Phase 2 study testing axelopran in people with Breast Cancer and Lung Cancer, run by HealthPartners Institute at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Lung Cancer, Pancreas Cancer
- What is being tested?
- axelopran
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Apr 2026to 1 Nov 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (aged 18 or more at enrollment).
- Histologically or cytologically proven cancer of the prostate (carcinoma), breast (carcinoma), pancreas (carcinoma), and lung (non-small cell lung carcinoma (NSCLC)) that has relapsed or progressed on or after a standard systemic treatment that has included cytotoxic chemotherapy.
- Advanced stage (locally advanced or metastatic) with no definitive plans for curative-intent therapy.
- A minimum life expectancy of at least 2 months at the time of the screening visit.
- Current use of an opioid medication with an average of 5mg OME/day over the past 3 days.
- At least one measurable lesion meeting RECIST v1.1 criteria.
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- At least 2 weeks since last cancer-directed therapy:
- NSCLC and pancreatic cancer must have received at least one line of systemic cytotoxic chemotherapy (+/- immune checkpoint inhibitor) in the locally advanced/metastatic setting.
- Breast cancer must be considered refractory to hormone therapy (i.e., progressed on standard estrogen blocking therapy) or hormone negative (i.e., estrogen and progesterone-receptor negative) and have received at least one line of systemic cytotoxic chemotherapy in the locally advanced/metastatic setting.
- Prostate cancer must be considered metastatic castrate-resistant prostate cancer (mCRPC) and have progressed on at least one androgen receptor pathway inhibitor (ARPI) and docetaxel. Docetaxel could be given in the metastatic castrate-sensitive setting, and/or later in the mCRPC setting. Baseline testosterone level must be <50 ng/dL and surgical or ongoing medical castration must be maintained throughout the duration of the study.
- Patients must a) have relapsed or progressed on or after all standard therapy, b) be intolerant to standard therapy, c) not have standard therapy available that confers a significant clinical benefit, d) decline other standard therapy or agree with treating oncologist that a period of active surveillance off therapy is reasonable.
- Clinician and patient are 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 next line of therapy at any time if a patient's clinical course changes and urgent new treatment is required. Patients will be allowed to remain on axelopran if that occurs.
- Planned palliative radiation therapy should be completed prior to study enrollment. Palliative radiation done during the primary study period would be considered next line of cancer therapy.
- Must be willing to report baseline and required patient-reported outcomes and report daily bowel movement frequency for monitoring stool changes.
- For a female subject of childbearing potential, must have documentation of a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1. All women are considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 2 years) or documented to be surgically sterile (bilateral tubal ligation or hysterectomy).
- Sexually active subjects must use a highly effective method of contraception during the study and for at least 90 days after completion of study drug dosing.
- A highly effective method of birth control is defined as one that results in a low failure rate (i.e., < 1% per year) when used consistently and correctly, such as condom + diaphragm, condom + spermicide, diaphragm + spermicide, or intrauterine device (IUD) with documented failure rate of < 1% per year, or oral/injectable/implanted hormonal contraceptives used in combination with an additional barrier method.
- Males should refrain from donating sperm during the study and for 90 days after completion of study drug.
Who cannot join
- Any previous gastrointestinal surgery, except uncomplicated appendectomy or cholecystectomy.
- Any of the included cancer cohorts where active malignancy causes direct extension/invasion of the GI tract from local spread or distant metastasis.
- Current, active, untreated brain metastases.
- History of fecal incontinence/impaction; irritable bowel syndrome; inflammatory bowel disease; intestinal obstruction; GI or pelvic disorders known to affect bowel transit, produce GI obstruction, or contribute to bowel dysfunction; fecal impaction requiring medical intervention within 1 month of enrollment.
- Subject is unable to eat, drink, take, or hold down oral medications.
- Use of buprenorphine, alvimopan, naltrexone, methylnaltrexone, naloxone, lubiprostone, linaclotide, or tapentadol therapy within 14 days before enrollment and inability or unwillingness to discontinue use until the end of the study.
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- Receipt of strong inhibitors of CYP3A4 (e.g., antifungal azoles, grapefruit juice) or strong inducers of CYP3A4 (e.g., rifampin or carbamazepine), including any herbal medications such as St. John's Wort, within the last 14 days or 5 half-lives, whichever is longer, prior to study drug administration.
- Receipt of inhibitors of p-glycoprotein (P-gp) within the last 14 days prior to study drug administration.
- Receipt of anti-VEGF therapies (i.e. bevacizumab) within the last 30 days prior to study drug administration.
- Subjects with clinically significant abnormal ECG at screening or before randomization in the opinion of the Investigator, or a QTc > 470 msec (per Fridericia's correction).
- Presence of unstable diseases, in the opinion of the Investigator, such as cardiovascular (e.g., acute myocardial infarction or acute coronary syndrome < 3 month history), respiratory (e.g., requires oxygen), gastrointestinal (e.g., symptomatic diverticulitis, irritable bowel syndrome [IBS], etc.), endocrine (e.g., uncontrolled diabetes or A1c > 10%), hematologic, neurologic, psychiatric (e.g., schizophrenia, unstable anxiety disorder, acute psychosis, depression with suicidal ideation, etc.), or any other significant conditions that may affect subject assessment.
- Any other condition which, in the opinion of the investigator, could confound or interfere with evaluation of safety, efficacy, or tolerability of the investigational drug, or prevent compliance with the study protocol.
- Women who are pregnant, breastfeeding, or of childbearing potential without the use of birth control.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
HealthPartners Frauenshuh Cancer Research Center
Saint Louis Park, Minnesota, 55426
Alissa Gavenda, RN, 952-993-6705, alissa.gavenda@parknicollet.com
- Recruiting
HealthPartners Cancer Center at Regions Hospital
Saint Paul, Minnesota, 55101
Lisa Wahowske, RN, 651-254-1517, lisa.wahowske@parknicollet.com
About this study
Official title: A Phase II Trial of Cancer Response Using Axelopran in Patients With Advanced Cancers on Opioids (AxeCan)
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?
Read more
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
- Breast Cancer, Lung Cancer, Pancreas Cancer, Prostate Cancer
- Being tested
- axelopran
- Keywords
- cancer, axelopran, opioids
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Pancreatic Neoplasms, Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
axelopranDrug
axelopran capsules
| Study group | Role | What they receive |
|---|---|---|
| Axelopran monotherapy | Experimental | axelopran capsules administered daily as monotherapy Receives: Drug: axelopran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (including complete response and partial response)
Calculate objective response rate (including complete response and partial response) at day 43 based on RECIST 1.1 (and PCWG3 for prostate cohort) criteria.
Measured: 43 days
Secondary outcomes (4)
Disease control rate (DCR)
Determine the disease control rate (DCR) (defined as the percentage of patients who achieve a CR, partial response, or stable disease) and progression-free survival based on RECIST 1.1 (and PCWG3 for prostate cohort) criteria.
Measured: 43 days
Impact on ctDNA
Assess the change in cancer-specific tumor markers (if applicable) and ctDNA from baseline to day 43.
Measured: 43 days
Impact on bowel function
Evaluate the bowel function and patient-reported outcomes related to constipation associated with use of axelopran.
Measured: 43 days
Impact on systemic inflammation
Conduct correlative studies on systemic inflammation as assessed through routine collection of albumin, neutrophil/lymphocyte ratios, and inflammatory markers (ESR, CRP, IL-6, and TNFa).
Measured: Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start27 Apr 2026
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Glycyx MOR Inc.
- Responsible party
- Sponsor
- Investigators
- Dylan Zylla, MD, MS, Principal investigator, HealthPartners Institute Cancer Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354919
- Sponsor's protocol ID
- AxeCan
- Acronym
- AxeCan
- Status last verified
- Apr 2026
- First submitted
- 19 Jan 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Cancer Response Using Axelopran in Patients With Advanced Cancers on Opioids (AxeCan)
- ClinicalTrials.gov ID
- NCT07354919
- Acronym / sponsor ID
- AxeCan / AxeCan
- Conditions
- Breast Cancer, Lung Cancer, Pancreas Cancer, Prostate Cancer
- Keywords
- cancer, axelopran, opioids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- Glycyx MOR Inc.
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Axelopran monotherapy | Experimental | Drug: axelopranaxelopran capsules administered daily as monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Adults (aged 18 or more at enrollment).
- Histologically or cytologically proven cancer of the prostate (carcinoma), breast (carcinoma), pancreas (carcinoma), and lung (non-small cell lung carcinoma (NSCLC)) that has relapsed or progressed on or after a standard systemic treatment that has included cytotoxic chemotherapy.
- Advanced stage (locally advanced or metastatic) with no definitive plans for curative-intent therapy.
- A minimum life expectancy of at least 2 months at the time of the screening visit.
- Current use of an opioid medication with an average of 5mg OME/day over the past 3 days.
Key exclusion criteria (13 listed)
- Any previous gastrointestinal surgery, except uncomplicated appendectomy or cholecystectomy.
- Any of the included cancer cohorts where active malignancy causes direct extension/invasion of the GI tract from local spread or distant metastasis.
- Current, active, untreated brain metastases.
- History of fecal incontinence/impaction; irritable bowel syndrome; inflammatory bowel disease; intestinal obstruction; GI or pelvic disorders known to affect bowel transit, produce GI obstruction, or contribute to bowel dysfunction; fecal impaction requiring medical intervention within 1 month of enrollment.
- Subject is unable to eat, drink, take, or hold down oral medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| axelopranaxelopran capsules | Drug | Axelopran monotherapy |
Primary outcome
Objective response rate (including complete response and partial response)
Time frame: 43 days
Calculate objective response rate (including complete response and partial response) at day 43 based on RECIST 1.1 (and PCWG3 for prostate cohort) criteria.
4 secondary outcomes
Disease control rate (DCR)
Time frame: 43 days
Impact on ctDNA
Time frame: 43 days
Impact on bowel function
Time frame: 43 days
Impact on systemic inflammation
Time frame: Day 43
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dylan Zylla, MD, MS principal investigator
HealthPartners Institute Cancer Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing axelopran in people with Breast Cancer and Lung Cancer, run by HealthPartners Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jordan Cowger, MPH (952-993-6071, jordan.cowger@parknicollet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (including complete response and partial response) (time frame: 43 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.