Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07354919 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Axelopran for Advanced Cancer in Patients Receiving Opioids

Study acronym: AxeCan
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened Primary completion pushed from Sep 1, 2027 to Nov 1, 2027 · Completion pushed from Sep 1, 2028 to Nov 1, 2028 · Start date changed from estimate of Mar 1, 2026 to Apr 27, 2026 · 3 morev2 Show 6 more changesShow less
    • Primary completion pushed from Sep 1, 2027 to Nov 1, 2027
    • Completion pushed from Sep 1, 2028 to Nov 1, 2028
    • Start date changed from estimate of Mar 1, 2026 to Apr 27, 2026
    • Eligibility criteria expanded, about 19 words
    • Site details revised at 2 of 2 sites
    • Study title expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
5,213 trials monitored
See 271 trials at risk
4,057 trials monitored
See 217 trials at risk
2,487 trials monitored
See 160 trials at risk
and 1 more disease
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
Trial Details
NCT Number NCT07354919
Lead Sponsor HealthPartners Institute
Collaborators: Glycyx MOR Inc.
Conditions Breast Cancer, Lung Cancer, Pancreas Cancer, Prostate Cancer
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov