Study of Pasireotide Treatment for Adults with Prolactin-Producing Pituitary Tumors Not Suitable for Dopamine Agonist Therapy

What this Trial Is About

Researchers are evaluating pasireotide as a treatment for people with prolactinoma who cannot use dopamine agonist therapy. The study aims to assess whether pasireotide is effective and safe for these patients, focusing on those with intolerance, contraindications, or resistance to dopamine agonists. This is a Phase 2 interventional study sponsored by Memorial Sloan Kettering Cancer Center. All participants will begin open-label treatment with pasireotide long-acting release LAR, starting with a 40 mg intramuscular dose in the first week. If tolerated, the dose will be increased to 60 mg every 4 weeks, with adjustments based on response and tolerability as judged by the investigator. Patients will return to the study center every 28 days - 7 days for medication administration and evaluation. Participants will be monitored through blood tests, tumor measurements, and patient questionnaires at baseline, week 12, 24, and 28. Researchers will track biochemical response within 24 weeks to measure treatment effect and radiographic response during the same period. Safety and tolerability assessments will be ongoing, and patients may continue treatment and follow-up as per study protocol until February 2027.

A Study of Pasireotide in People With Prolactinoma