A Study of Pasireotide in People With Prolactinoma (NCT06295952) | Clinical Trial Compass
RecruitingPhase 2
A Study of Pasireotide in People With Prolactinoma
United States10 participantsStarted 2024-02-27
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age 18 or older
✓. Male and female patients with prolactinomas with at least one of the following criteria:
✓. 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 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.
Exclusion criteria
✕. 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