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NCT07354919 · ClinicalTrials.gov registry record · Phase 2
Axelopran for Advanced Cancer in Patients Receiving Opioids
A Phase 2 study, sponsored by HealthPartners Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT07354919: Recruiting Phase 2 study, sponsored by HealthPartners Institute.
NCT07354919 is a Phase 2 study that is actively recruiting participants, run by HealthPartners Institute. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07354919, a Phase 2 study, is actively recruiting participants, sponsored by HealthPartners Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study 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). 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
Primary Outcome
Calculate objective response rate (including complete response and partial response) at day 43 based on RECIST 1.1 (and PCWG3 for prostate cohort) criteria.
Interventions
- DRUG axelopran
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2026-04-27 |
| Est. Completion | 2028-11-01 |
| Phase | Phase 2 |
What NCT07354919 shows while recruiting
NCT07354919 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 1 intervention - of which axelopran is the first listed.
NCT07354919 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07354919 about?
NCT07354919 is a clinical study titled "Axelopran for Advanced Cancer in Patients Receiving Opioids". 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 que...
What is the current status of trial NCT07354919?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2026-04-27. Estimated completion is 2028-11-01.
What interventions are being tested in trial NCT07354919?
The interventions under investigation include: axelopran (DRUG).
Who is sponsoring clinical trial NCT07354919?
This trial is sponsored by HealthPartners Institute, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07354919's enrollment target sits among peer trials
34 1539th of 2000 higher than 448 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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