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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

⁃ 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

⁃ 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 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.

⁃ 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.

Locations
United States
New Jersey
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
RECRUITING
Uniondale
Contact Information
Primary
Eliza Geer, MD
geere@mskcc.org
646-608-3797
Backup
Andrew Lin, MD
212-639-8392
Time Frame
Start Date: 2024-02-27
Estimated Completion Date: 2027-02
Participants
Target number of participants: 10
Treatments
Experimental: Pasireotide
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. 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.
Sponsors
Collaborators: RECORDATI GROUP
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov

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