RECRUITING

A Study of Pasireotide in People With Prolactinoma

Conditions

Prolactin-Producing Pituitary Tumor pasireotide dopamine agonist 23-371

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pasireotide Treatment for Patients With Prolactinomas Who Need Treatment Beyond Dopamine Agonist Therapy

Quick Facts

Study Start:2024-02-27

Study Completion:2027-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06295952

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 18 or older 2. Male and female patients with prolactinomas and hyperprolactinemia 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 bromocriptine. Patients with a partial response to DA, including a prolactin reduction but not normalization on treatment, will be included, and will continue DA during the study. 3. 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). 4. 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. 5. At least 8 weeks washout of prior first-generation somatostatin receptor ligand therapy (octreotide or lanreotide). 6. Patients on temozolomide will need a washout period of at least 3 weeks. 7. Patients on carboplatin, cisplatin or etoposide will need a washout period of at least 4 weeks. 8. 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. 9. In general, at least 4 weeks must have elapsed from any other anticancer drug therapy (e.g., bevacizumab). 10. 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. 11. 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 subjects 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 12. Karnofsky Performance Status (KPS) 70 or above 13. Measurable tumor by RECIST V1.1 criteria, ≥ 10 mm. 14. 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 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. Women who are not of childbearing potential are not required to use contraception. * Women of childbearing potential must have a negative serum or urine pregnancy test upon study entry. 15. 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.	1. Additional pituitary tumor directed therapy, including temozolomide, everolimus, lapatinib, or cytotoxic chemotherapy 2. Concurrent malignancy except non-melanoma skin cancer 3. Any pituitary surgery within 14 days of enrollment. 4. Patients with poorly controlled diabetes as defined by HBA1c \>9% or not optimally treated for diabetes mellitus as judged by the investigator 5. Patients who are not euthyroid as judged by the investigator 6. 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 7. Patients with QTc \> 500 ms 8. History of intolerance or resistance to pasireotide 9. Women who are pregnant or breast-feeding 10. Inability to undergo radiographic surveillance 11. Inability to provide informed consent

Inclusion Criteria

Exclusion Criteria

1. Age 18 or older
2. Male and female patients with prolactinomas and hyperprolactinemia 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 bromocriptine. Patients with a partial response to DA, including a prolactin reduction but not normalization on treatment, will be included, and will continue DA during the study.
3. 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).
4. 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.
5. At least 8 weeks washout of prior first-generation somatostatin receptor ligand therapy (octreotide or lanreotide).
6. Patients on temozolomide will need a washout period of at least 3 weeks.
7. Patients on carboplatin, cisplatin or etoposide will need a washout period of at least 4 weeks.
8. 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.
9. In general, at least 4 weeks must have elapsed from any other anticancer drug therapy (e.g., bevacizumab).
10. 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.
11. 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 subjects 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
12. Karnofsky Performance Status (KPS) 70 or above
13. Measurable tumor by RECIST V1.1 criteria, ≥ 10 mm.
14. 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 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. Women who are not of childbearing potential are not required to use contraception.
* Women of childbearing potential must have a negative serum or urine pregnancy test upon study entry.
15. 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.

1. Additional pituitary tumor directed therapy, including temozolomide, everolimus, lapatinib, or cytotoxic chemotherapy
2. Concurrent malignancy except non-melanoma skin cancer
3. Any pituitary surgery within 14 days of enrollment.
4. Patients with poorly controlled diabetes as defined by HBA1c \>9% or not optimally treated for diabetes mellitus as judged by the investigator
5. Patients who are not euthyroid as judged by the investigator
6. 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
7. Patients with QTc \> 500 ms
8. History of intolerance or resistance to pasireotide
9. Women who are pregnant or breast-feeding
10. Inability to undergo radiographic surveillance
11. Inability to provide informed consent

Contacts and Locations

Study Contact

Eliza Geer, MD

CONTACT

646-608-3797

geere@mskcc.org

Andrew Lin, MD

CONTACT

212-639-8392

Principal Investigator

Eliza Geer, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Eliza Geer, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-27

Study Completion Date2027-02

Study Record Updates

Study Start Date2024-02-27

Study Completion Date2027-02

Terms related to this study

Keywords Provided by Researchers

pasireotide
dopamine agonist
23-371

Additional Relevant MeSH Terms

Prolactin-Producing Pituitary Tumor