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Corticosteroid

Pasireotide for Prolactinoma

Phase 2

Recruiting

Led By Eliza Geer, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 24 weeks of treatment

Awards & highlights

Study Summary

"This trial is investigating whether pasireotide is an effective and safe treatment for people with prolactinoma who cannot use dopamine agonist therapy."

Who is the study for?

This trial is for adults with prolactinoma who can't take dopamine agonist therapy, aren't candidates for surgery, and meet specific health criteria. They must not have other cancers (except non-melanoma skin cancer), be pregnant or breastfeeding, have had recent pituitary surgery, poorly controlled diabetes, liver disease, or a prolonged QTc interval.Check my eligibility

What is being tested?

The study tests the effectiveness and safety of Pasireotide in treating prolactinoma among patients intolerant to standard treatment. It aims to see if this drug can manage tumor-related high prolactin levels without causing significant harm.See study design

What are the potential side effects?

Pasireotide may cause side effects like gastrointestinal disturbances (nausea, diarrhea), changes in blood sugar levels, fatigue, headache, liver function alterations and possibly heart rhythm changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 24 weeks of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 24 weeks of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 24 weeks of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

biochemical response rate

Secondary outcome measures

radiographic response

Side effects data

From 2012 Phase 2 & 3 trial • 21 Patients • NCT01620138

Hyperglycemia

Diarrhea

100%

80%

60%

40%

20%

Study treatment Arm

Pasireotide

Cabergoline

Trial Design

1Treatment groups

Experimental Treatment

Group I: PasireotideExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pasireotide

2004

Completed Phase 3

~1350

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Recordati Pharmaceutical companyUNKNOWN

Evergreen TheragnosticsUNKNOWN

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,888 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently any available slots for new participants in this medical trial?

"According to the information available on clinicaltrials.gov, this research endeavor is currently in need of volunteers. The trial was initially uploaded on February 27th, 2024 and underwent its latest revision on February 28th, 2024."

Answered by AI

What is the cumulative count of individuals participating in this medical study?

"Indeed, the details on clinicaltrials.gov indicate that this research venture is actively seeking volunteers. The trial was first shared on 2/27/2024 and had its latest update on 2/28/2024. There are openings for 10 participants spread across 7 different locations."

Answered by AI

Has Pasireotide received the official endorsement of the FDA?

"This Phase 2 trial evaluates the safety of Pasireotide, with our team assigning a safety rating of 2 due to existing safety data but an absence of efficacy findings."

Answered by AI

At present, how many distinct locations are simultaneously conducting this experimental investigation?

"At sites like Memorial Sloan Kettering Monmouth, Basking Ridge, and Suffolk-Commack (with Limited Protocol Activities), as well as seven additional locations, a total of 7 patients are currently being recruited for this clinical investigation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Pasireotide in People With Prolactinoma

2024. "A Study of Pasireotide in People With Prolactinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06295952.

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