Axelopran for Advanced Cancer in Patients Receiving Opioids

Part of paid clinical trials in Saint Louis Park, Minnesota.

Sponsor
HealthPartners Institute
Study ID
NCT07354919
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • axelopran — DRUG
    axelopran capsules

Study Details

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

Key Dates

Start date
Apr 27, 2026
Status verified
Apr 2026
Primary completion
Nov 1, 2027
Completion
Nov 1, 2028

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Axelopran monotherapy
    axelopran capsules administered daily as monotherapy

Primary Outcome Measure

Objective response rate (including complete response and partial response) [ Time Frame: 43 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
HealthPartners Frauenshuh Cancer Research CenterSaint Louis ParkMinnesota55426
Alissa Gavenda, RN
[email protected]
952-993-6705
HealthPartners Cancer Center at Regions HospitalSaint PaulMinnesota55101
Lisa Wahowske, RN
[email protected]
651-254-1517

Find similar trials in Saint Louis Park, MN

By condition
Breast cancerLung cancerProstate cancer
By specialty
OncologyBreast oncologyWomen's healthLung oncologyLung diseaseProstate oncologyMen's healthUrology
By research site
HealthPartners Frauenshuh Cancer Research Center· Saint Louis Park, MNHealthPartners Cancer Center at Regions Hospital· Saint Paul, MN

Related Studies