Trial · Interventional
RecruitingPhase 2Registry dataA Study of Pasireotide in People With Prolactinoma
Overview
- Status
- Recruiting
- Phase
- Phase 2
- Enrollment
- 10 participants (estimated)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Other
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
United States
- Start
- 27 Feb 2024
- Primary completion
- Feb 2027 (estimated)
- Completion
- Feb 2027 (estimated)
- First posted
- 6 Mar 2024
- Last update posted
- 4 Mar 2026
- Conditions
- Prolactin-Producing Pituitary Tumor
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- PasireotideDrug
- SF-36 and HADSOther
Arms1
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. 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.
Primary outcomes1
Outcomes the sponsor listed as primary.
biochemical response rate
Time frame · within 24 weeks of treatment
Registry description
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
Secondary outcomes(1)
radiographic response
Time frame · within 24 weeks of treatment
Registry description
RECIST criteria, V1.1 (30% decrease in longest tumor diameter)
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
PepBank is a research reference. Talk to a doctor before you use any peptide.