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New treatment option for Breast Cancer
Official title Axelopran for Advanced Cancer in Patients Receiving Opioids
ClinicalTrials.gov ID: NCT07354919
What this study is testing
What is axelopran?
axelopran is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 1 year
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
Who can 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...
- 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.
- 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...
- 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...
- 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...
- 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...
- 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...
- Sexually active people 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 +...
- Males should refrain from donating sperm during the study and for 90 days after completion of study drug.
What rules you out
- 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...
- 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...
- 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...
- 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.
- people 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 \ 10%), hematologic, neurologic, psychiatric (e.g., schizophrenia...
- Any other condition which, in the opinion of the investigator, could confound or interfere with evaluation of safety, how well it works, or side effects of the investigational drug, or prevent compliance with the study...
- Women who are pregnant, breastfeeding, or of childbearing potential without the use of birth control.
The study team makes the final eligibility decision.
Where it's taking place
- Saint Louis Park, Minnesota, United States
- Saint Paul, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint Louis Park, Minnesota, United States; Saint Paul, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.