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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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