Actively Recruiting
A Study of Pasireotide in People With Prolactinoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-04
10
Participants Needed
7
Research Sites
152 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
R
RECORDATI GROUP
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Pasireotide in People With Prolactinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Male and female patients with prolactinomas who have intolerance, contraindication, or resistance to dopamine agonist treatment
- Patients not considered candidates for surgery, including those with inoperable tumors or who refuse surgery
- At least 6 months since last pituitary radiation with stable or increasing prolactin levels or tumor growth
- At least 8 weeks washout from first-generation somatostatin receptor ligand therapy
- Washout period of at least 3 weeks if previously on temozolomide
- Washout period of at least 4 weeks if previously on carboplatin, cisplatin, or etoposide
- Washout period of at least 5 half-lives or 2 weeks for protein kinase inhibitors
- At least 4 weeks since any other anticancer drug therapy
- Stable or lower dose of dopamine agonist treatment for at least one month if continuing during study
- Screening labs within specified limits for blood counts, liver function, and kidney function
- Karnofsky Performance Status of 70 or above
- Measurable tumor of at least 10 mm by RECIST V1.1 criteria
- Women of childbearing potential must use contraception and have negative pregnancy test
- Sexually active men with partners of childbearing potential must use contraception
You will not qualify if you...
- Receiving additional pituitary tumor therapies such as temozolomide, everolimus, lapatinib, or chemotherapy
- Having another active cancer except non-melanoma skin cancer
- Pituitary surgery within 14 days before enrollment
- Poorly controlled diabetes or not optimally treated diabetes
- Not having normal thyroid function as judged by investigator
- Liver disease such as cirrhosis or chronic hepatitis, or elevated liver enzymes exceeding limits
- QTc interval greater than 500 ms
- History of intolerance or resistance to pasireotide
- Pregnant or breastfeeding women
- Unable to undergo radiographic monitoring
- Unable to provide informed consent
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
E
Eliza Geer, MD
CONTACT
A
Andrew Lin, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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