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Somatostatin Analog

Pasireotide for Cushing's Disease

Phase 4
Waitlist Available
Research Sponsored by RECORDATI GROUP
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 baseline up to approximately 10 years
Awards & highlights

Study Summary

This trial will allow patients who are benefiting from pasireotide treatment to continue receiving the medication.

Eligible Conditions
  • Cushing's Disease
  • Dumping Syndrome
  • Melanoma
  • Prostate Cancer
  • Neuroendocrine Tumors
  • Pituitary Tumors
  • Acromegaly
  • ACTH Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to approximately 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events to evaluate long term safety data
Secondary outcome measures
Percentage of patients with clinical benefit as assessed by the investigator

Side effects data

From 2012 Phase 2 & 3 trial • 21 Patients • NCT01620138
8%
Hyperglycemia
8%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pasireotide
Cabergoline

Trial Design

2Treatment groups
Experimental Treatment
Group I: Pasireotide subcutaneousExperimental Treatment2 Interventions
0.3mg, 0.6mg and 0.9mg. Doses to be taken BID or TID, dependent on parent study guidelines. Cabergoline may be combined in this arm for Cushing's Disease and Acromegaly patients.
Group II: Pasireotide Long Acting Release (LAR)Experimental Treatment1 Intervention
10mg, 20mg, 40mg and 60mg. All doses to be taken q28days. Strength is dependent on parent study guidelines.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pasireotide
2004
Completed Phase 3
~1350
Cabergoline
2021
Completed Phase 4
~1300

Find a Location

Who is running the clinical trial?

RECORDATI GROUPLead Sponsor
12 Previous Clinical Trials
4,146 Total Patients Enrolled
2 Trials studying Cushing's Disease
212 Patients Enrolled for Cushing's Disease
RecordatiStudy DirectorRecordati AG
2 Previous Clinical Trials
380 Total Patients Enrolled
1 Trials studying Cushing's Disease
200 Patients Enrolled for Cushing's Disease

Frequently Asked Questions

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

How many research facilities are presently engaging in this trial?

"This clinical trial has 10 enrollment sites, such as Cedars Sinai Medical Centre in Los Angeles and Virginia Endocrinology Research SC in Chesapeake. Additionally, Ximed Research SC - SOM230B2412 is also offering this medication to patients located in La Jolla, alongside the other 7 participating locations."

Answered by AI

Are there other scientific investigations that have used Pasireotide in the past?

"Currently, there are 8 clinical trials researching Pasireotide with one in the terminal phase. Despite being based out of Boston, Massachusetts; this trial is running at 99 locations worldwide."

Answered by AI

Is this trial open to new participants?

"According to the clinicaltrials.gov listing, this trial is no longer recruiting participants after its last update on May 19th 2022. Nevertheless, there are currently 2262 other studies actively searching for study volunteers."

Answered by AI

What ailments is Pasireotide most commonly deployed to address?

"Pasireotide is a popular choice for preventing lactation, as well as treating cushing's disease, pituitary adenoma, and idiopathic hyperprolactinemic disorder."

Answered by AI

How many patients are currently enrolled in this clinical exploration?

"Unfortunately, this research project is not presently seeking any additional participants. The initial posting was made on June 10th 2013 and the last update occurred on May 19th 2022. To find alternative studies of this type, there are currently 2254 trials recruiting patients with neuroendocrine tumors plus 8 clinical investigations which require volunteers for Pasireotide-related treatments."

Answered by AI

Has Pasireotide obtained authorization from the Food and Drug Administration?

"Pasireotide has been approved for use, so it is rated a 3 in terms of safety. This assessment was conducted by Power's research team and reflects the fact that this medication is currently in Phase 4 clinical trials."

Answered by AI

Does this research represent a new approach to the field?

"As of now, 8 clinical experiments for Pasireotide are occurring in 41 cities and 31 nations. This drug was first trialled in 2013 by RECORDATI GROUP with 413 participants participating until its Phase 4 stage. Since then, 84 studies have been successfully concluded."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
How old are they?
18 - 65
What site did they apply to?
Recordati Investigative Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies
2013. "Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01794793.
~35 spots leftby Apr 2025
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