Health TrialsbyHealthPanel

Axelopran for Advanced Cancer in Patients Receiving Opioids

ConditionsBreast CancerLung CancerPancreas CancerProstate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHealthPartners Institute

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 standard systemic treatment that has included cytotoxic chemotherapy.

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.

Disqualifiers

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 dysfunction; fecal impaction requiring medical intervention within 1 month of enrollment.

Trial design

Design model

Single group

Treatments tested in this trial

  • axelopran

    Drug

    axelopran capsules

Treatment groups

34 Participants
are divided into 1 treatment group
Group A: Axelopran monotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate (including complete response and partial response)

Calculate objective response rate (including complete response and partial response) at day 43 based on RECIST 1.1 (and PCWG3 for prostate cohort) criteria.

Time frame
43 days

Secondary outcomes

1

Disease control rate (DCR)

Determine the disease control rate (DCR) (defined as the percentage of patients who achieve a CR, partial response, or stable disease) and progression-free survival based on RECIST 1.1 (and PCWG3 for prostate cohort) criteria.

Time frame
43 days
2

Impact on ctDNA

Assess the change in cancer-specific tumor markers (if applicable) and ctDNA from baseline to day 43.

Time frame
43 days
3

Impact on bowel function

Evaluate the bowel function and patient-reported outcomes related to constipation associated with use of axelopran.

Time frame
43 days
4

Impact on systemic inflammation

Conduct correlative studies on systemic inflammation as assessed through routine collection of albumin, neutrophil/lymphocyte ratios, and inflammatory markers (ESR, CRP, IL-6, and TNFa).

Time frame
Day 43

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HealthPartners Institute

Lead sponsor

Glycyx MOR Inc.

Collaborator

Source ClinicalTrials.gov
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