Phase II Study of Axelopran as Monotherapy for Advanced Lung, Breast, Pancreas, and Prostate Cancers in Patients Using Opioids

What this Trial Is About

Researchers are evaluating axelopran, an oral capsule treatment, in patients with advanced cancers of the lung, breast, pancreas, and prostate who are currently using opioids. This phase II, single-arm, open-label trial aims to explore if axelopran can slow tumor progression, improve bowel function and quality of life, reduce inflammation and cachexia, and assess its safety and tolerability over long-term use. Participants have relapsed or progressed after standard systemic therapies. Participants will take axelopran capsules daily as monotherapy for up to one year or longer if benefiting from the treatment. The main study period for assessing impact on cancer control is through day 43 6 weeks. They will attempt to delay starting the next line of systemic cancer therapy until after this period, with flexibility to start earlier if needed. The study involves 10 in-person visits including imaging exams, blood draws, electronic surveys, and physical assessments. During the trial, participants will attend visits lasting 1 to 2 hours each, complete patient-reported outcomes, and track daily bowel movements. Researchers will measure objective tumor response, disease control rate, circulating tumor DNA changes, bowel function, and systemic inflammation. Safety and tolerability will be monitored throughout, and the total participation may extend up to or beyond one year depending on benefit.

Axelopran for Advanced Cancer in Patients Receiving Opioids