Actively Recruiting
Pasireotide Treatment for Patients With Prolactinomas Who Need Treatment Beyond Dopamine Agonist Therapy
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-04
10
Participants Needed
7
Research Sites
N/A
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
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.
CONDITIONS
Brief Title
A Study of Pasireotide in People With Prolactinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or older
- Male and female patients with prolactinomas who have intolerance, contraindication, or resistance to dopamine agonist therapy
- Not candidates for surgery due to medical reasons or personal choice
- At least 6 months since last pituitary radiation if applicable, with stable or increasing prolactin levels or tumor growth
- At least 8 weeks washout from prior first-generation somatostatin receptor ligand therapy
- Required washout periods from certain anticancer drugs as specified
- Stable or lower dose of dopamine agonist for at least one month if continuing treatment
- Adequate laboratory values including blood counts, liver and kidney function
- Karnofsky Performance Status 70 or above
- Measurable tumor size of at least 10 mm by RECIST criteria
- Women of childbearing potential must use contraception and have a negative pregnancy test
- Men who are sexually active with women of childbearing potential must use contraception unless sterile
You will not qualify if you...
- Use of additional pituitary tumor therapies such as temozolomide, everolimus, lapatinib, or chemotherapy
- Concurrent cancer except non-melanoma skin cancer
- Pituitary surgery within 14 days before enrollment
- Poorly controlled diabetes or untreated diabetes
- Thyroid hormone imbalance as judged by the investigator
- Liver disease or abnormal liver tests exceeding defined limits
- QTc interval greater than 500 ms
- History of intolerance or resistance to pasireotide
- Pregnancy or breastfeeding
- Inability to undergo imaging surveillance
- Inability to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive pasireotide injections starting at 40 mg IM once, then increasing to 60 mg IM every 4 weeks if tolerated. Dose adjustments may occur based on response and tolerability.
Visits every 4 weeks (+/- 7 days) for medication administration and evaluation
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
A
Andrew Lin, MD
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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