Trial Title:
A Study of Pasireotide in People With Prolactinoma
NCT ID:
NCT06295952
Condition:
Prolactin-Producing Pituitary Tumor
Conditions: Official terms:
Pituitary Neoplasms
Prolactinoma
Pasireotide
Conditions: Keywords:
pasireotide
dopamine agonist
23-371
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
This is an open label single-center pilot study.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pasireotide
Description:
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.
Arm group label:
Pasireotide
Intervention type:
Other
Intervention name:
SF-36 and HADS
Description:
Baseline assessment will be conducted within 30 days of starting treatment, week 12, 24
and week 28.
Arm group label:
Pasireotide
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.
Criteria for eligibility:
Criteria:
Inclusion 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.
Exclusion Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Eliza Geer, MD
Phone:
646-608-3797
Facility:
Name:
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Eliza Geer, MD
Phone:
646-608-3797
Facility:
Name:
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Eliza Geer, MD
Phone:
646-608-3797
Facility:
Name:
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Eliza Geer, MD
Phone:
646-608-3797
Facility:
Name:
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Eliza Geer, MD
Phone:
646-608-3797
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Eliza Geer, MD
Phone:
646-608-3797
Contact backup:
Last name:
Andrew Lin, MD
Phone:
212-639-8392
Facility:
Name:
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Eliza Geer, MD
Phone:
646-608-3797
Start date:
February 27, 2024
Completion date:
February 2027
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Collaborator:
Agency:
Recordati Pharmaceutical company
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06295952
http://www.mskcc.org/mskcc/html/44.cfm
