A Study of Pasireotide in People With Prolactinoma

NCT06295952 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 23-371
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Prolactin-Producing Pituitary Tumor

Keywords

pasireotide; dopamine agonist; 23-371

Outcome Measures

Primary Outcomes (1)

• biochemical response rate

  response rate as defined by a normal serum prolactin concentration (\<18.0 ng/ml for a male and \< 29.0 ng/ml for a female

  within 24 weeks of treatment

Secondary Outcomes (1)

• radiographic response

  within 24 weeks of treatment

Study Arms (1)

Pasireotide

EXPERIMENTAL

All patients will initiate open-label treatment with pasireotide LAR on week 1 in the outpatient setting. Pasireotide will be initiated at 40 mg IM one time dose and if tolerated dose will be increased to 60 mg IM every 4 weeks +/-7 days. Additional dose adjustments will be allowed as per PI judgement, based on response and tolerability. Administration of pasireotide will align with package inset. Patients must return to the study center every 28 days (+/- 7 days) to receive study medication and for evaluation.

Drug: Pasireotide; Other: SF-36 and HADS

Interventions

Pasireotide DRUG

Pasireotide will be initiated at 40 mg IM one time dose and if tolerated dose will be increased to 60 mg IM every 4 weeks +/-7 days.

Pasireotide

SF-36 and HADS OTHER

Baseline assessment will be conducted within 30 days of starting treatment, week 12, 24 and week 28.

Pasireotide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.
• 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.

You may not qualify 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 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• RECORDATI GROUP: collaborator

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Interventions

pasireotide; 4-amino-4'-hydroxylaminodiphenylsulfone

Study Officials

• Eliza Geer, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eliza Geer, MD

CONTACT

646-608-3797; geere@mskcc.org

Andrew Lin, MD

CONTACT

212-639-8392

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open label single-center pilot study.

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 6, 2024
• Study Start: February 27, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (7)