BridgeMD
New treatment option for Prolactin-Producing Pituitary Tumor
Official title A Study of Pasireotide in People With Prolactinoma
ClinicalTrials.gov ID: NCT06295952
What this study is testing
What is Pasireotide?
Pasireotide is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for prolactin-producing pituitary tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
You likely can't join 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...
See the full eligibility criteria
- 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...
- 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 people 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.
- Women of childbearing potential (WOCBP) must use appropriate methods of contraception while participating in the trial until 30 days after the follow-up period.
- WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12...
- Women of childbearing potential must have a negative serum or urine pregnancy test upon study entry.
- Men who are sexually active with women of childbearing potential must use adequate contraception while participating in the trial. Men who are surgically sterile or azoospermia do not require contraception.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.