A Study of Pasireotide in People With Prolactinoma

Recruiting now · Phase 2

Conditions studied: Prolactin-Producing Pituitary Tumor

In brief

The researchers are doing this study to find out whether pasireotide is an effective treatment for people with prolactinoma who cannot receive dopamine agonist therapy. Another purpose of this study is to find out whether pasireotide is a safe treatment for people with prolactinoma.

Key facts

Study ID: NCT06295952
Run by: Memorial Sloan Kettering Cancer Center
People needed: 10
Starts: 2024-02-27
Expected to finish: 2027-02-01
Last updated by the study team: 2026-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age 18 or older
Male and female patients with prolactinomas with at least one of the following criteria:
Clinical intolerance due to adverse events on DA treatment, preventing continued treatment.
Contraindication to DA treatment (e.g., patients requiring dopamine antagonist therapy or other therapy that is contraindicated).
Tumor resistance to DA, defined as <50% decrease in longest diameter, or progression in tumor size and/or lack of prolactin normalization with at least 2 mg per week, or maximally tolerated dose, of cabergoline or bromocriptine. Patients with a partial response to DA, including a prolactin reduction but not normalization on treatment, will be included, and will continue DA during the study.
Patients are not considered candidates for surgery (e.g., poor surgical candidates, inoperable tumors, patients who refuse surgical treatment, or for whom surgery is deemed not appropriate treatment).
For patients with a history of pituitary radiation, the following criteria must be present:
At least 6 months must have elapsed from the time of the most recent radiation treatment to the time of enrollment, and
Stable or up trending serum prolactin levels and/or evidence of tumor growth since completion of radiation.
At least 8 weeks washout of prior first-generation somatostatin receptor ligand therapy (octreotide or lanreotide).
Patients on temozolomide will need a washout period of at least 3 weeks.
Patients on carboplatin, cisplatin or etoposide will need a washout period of at least 4 weeks.
Patients on protein kinase inhibitors (e.g., everolimus, lapatinib) will need a washout period of at least 5 half-lives or 2 weeks, whichever in longer.
In general, at least 4 weeks must have elapsed from any other anticancer drug therapy (e.g., bevacizumab).
Stable or lower dose of DA (cabergoline or bromocriptine) for at least one month for those patients continuing DA treatment, i.e. DA dose may not be escalated during trial enrollment.
Screening laboratory values must meet the following criteria:
WBC ≥ 2000/μL
Neutrophils ≥ 1500/μL
Platelets ≥ 100 x103/μL
Hemoglobin > 9.0 g/dL
AST/ALT ≤ 3 x ULN
Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min using the Cockcroft-Gault formula
Karnofsky Performance Status (KPS) 70 or above
Measurable tumor by RECIST V1.1 criteria, ≥ 10 mm.

You may not qualify if…

Additional pituitary tumor directed therapy, including temozolomide, everolimus, lapatinib, or cytotoxic chemotherapy
Concurrent malignancy except non-melanoma skin cancer
Any pituitary surgery within 14 days of enrollment.
Patients with poorly controlled diabetes as defined by HBA1c >9% or not optimally treated for diabetes mellitus as judged by the investigator
Patients who are not euthyroid as judged by the investigator
Patient with liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis, or patients with serum ALT and/or AST >3x ULN, or total bilirubin >1.5 x ULN
Patients with QTc > 500 ms
History of intolerance or resistance to pasireotide
Women who are pregnant or breast-feeding
Inability to undergo radiographic surveillance
Inability to provide informed consent

Where it is running

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (enrolling)
Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (enrolling)
Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (enrolling)
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) — Commack, New York, United States (enrolling)
Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (enrolling)
Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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