Study on Axelopran for Advanced Cancer in Patients Using Opioids
Sponsor: HealthPartners Institute
ClinicalTrials ID:NCT07354919
This clinical trial is testing the effects of a drug called axelopran on cancer control in patients with advanced lung, breast, pancreas, and prostate cancers who are also using opioids. The study will last for six weeks to see if axelopran can slow down cancer growth, improve bowel function, and enhance quality of life.
Patient Parameters
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Program Overview
The main goal of this study is to find out if axelopran can help control cancer in patients with advanced lung, breast, pancreas, and prostate cancers who are taking opioids. Researchers want to see if axelopran can slow down tumor growth, improve bowel function, and enhance quality of life. Participants will take axelopran daily for up to a year and attend 10 study visits for tests and assessments. The study will also check if axelopran is safe for long-term use.
Description
Participants in this study will take axelopran capsules by mouth every day for up to one year, or longer if they are benefiting from the treatment. They will have 10 in-person visits, each lasting about 1-2 hours, where they will undergo various procedures such as imaging exams, blood tests, health surveys, and physical assessments. The study aims to determine if axelopran can slow cancer progression, improve bowel function, and enhance quality of life in patients with advanced cancers who are using opioids. Researchers will also evaluate the safety and tolerability of axelopran for long-term use.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older.
- Diagnosed with advanced lung, breast, pancreas, or prostate cancer that has worsened after standard treatment.
- Cancer is at an advanced stage and not planned for curative treatment.
- Life expectancy of at least 2 months.
- Currently using opioid medication.
- Have at least one measurable tumor.
- At least 2 weeks since last cancer treatment.
- Willing to delay next cancer treatment until day 43 of the study.
- Able to report bowel movement frequency and other health outcomes.
- Women of childbearing potential must have a negative pregnancy test and use effective birth control.
- Sexually active participants must use effective contraception during the study and for 90 days after.
Exclusion Criteria
- Previous major gastrointestinal surgery.
- Cancer affecting the gastrointestinal tract.
- Untreated brain metastases.
- History of bowel disorders or conditions affecting bowel function.
- Unable to take oral medications.
- Recent use of certain medications affecting bowel function.
- Use of certain medications affecting liver enzymes or drug metabolism.
- Recent use of anti-VEGF therapies.
- Abnormal heart tests or conditions affecting heart rhythm.
- Unstable medical conditions affecting major organs or systems.
- Any condition that could interfere with the study or its assessments.
- Women who are pregnant, breastfeeding, or not using birth control.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| HealthPartners Frauenshuh Cancer Research Center | 55426 | Saint Louis Park | Minnesota |
| HealthPartners Cancer Center at Regions Hospital | 55101 | Saint Paul | Minnesota |
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