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Somatostatin Analog

Paltusotine for Carcinoid Syndrome

Phase 2

Waitlist Available

Research Sponsored by Crinetics Pharmaceuticals Inc.

Eligibility Criteria Checklist

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

Must have

Documented carcinoid syndrome requiring medical therapy

Evaluable documentation of locally advanced or metastatic histopathologically confirmed well-differentiated neuroendocrine tumor (NET)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at week 8

Awards & highlights

Study Summary

This trial is testing a new drug for carcinoid syndrome to see if it is safe and effective. The study has two parts, a Randomized Treatment Phase and an Open-Label Extension (OLE) Phase.

Who is the study for?

This trial is for adults with carcinoid syndrome not currently treated with certain somatostatin receptor ligands or those controlled on lanreotide/octreotide. Participants should have stable disease, no recent other NET treatments, and can't have insulin-treated diabetes less than 6 weeks old, severe diarrhea from other causes, or require second-line treatments.Check my eligibility

What is being tested?

The study tests the safety and dose response of Paltusotine (80 mg or 40 mg) in patients with carcinoid syndrome. It includes a randomized phase where doses are compared by chance and an open-label phase where all receive the drug.See study design

What are the potential side effects?

While specific side effects aren't listed here, typically such trials monitor for digestive issues like diarrhea (given the condition), hormonal imbalances due to serotonin levels affected by tumors, and general medication reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am on medication for carcinoid syndrome.

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My cancer is a well-differentiated neuroendocrine tumor that has spread.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at week 8 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 treatment-emergent adverse events (TEAEs)

Secondary outcome measures

Pharmacokinetics (PK) of paltusotine

Trial Design

2Treatment groups

Experimental Treatment

Group I: 80 mg PaltusotineExperimental Treatment1 Intervention

Group II: 40 mg PaltusotineExperimental Treatment1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Crinetics Pharmaceuticals Inc.Lead Sponsor

11 Previous Clinical Trials

575 Total Patients Enrolled

Media Library

Paltusotine (Somatostatin Analog) Clinical Trial Eligibility Overview. Trial Name: NCT05361668 — Phase 2

Carcinoid Syndrome Research Study Groups: 40 mg Paltusotine, 80 mg Paltusotine

Carcinoid Syndrome Clinical Trial 2023: Paltusotine Highlights & Side Effects. Trial Name: NCT05361668 — Phase 2

Paltusotine (Somatostatin Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05361668 — Phase 2

Frequently Asked Questions

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

Are there numerous places where I can receive this treatment?

"You can find the six enrolling sites for this trial by visiting the locations page. The centres are situated in Newport Beach, Stanford, and Lexington as well other cities. If you decide to participate in this clinical study, try and pick a location that is close to minimize travel time and disruptions."

Answered by AI

Are there any limitations on how many people can be enrolled in this research?

"That is correct, the information on clinicaltrials.gov indicates that this trial is currently looking for enrollees. This particular study was first put up on 6/17/2022 and was last updated 10/5/2022. They are hoping to 30 individuals spread out between 6 sites."

Answered by AI

Are we still able to enroll patients in this research project?

"From what is available on clinicaltrials.gov, it appears that this study is still looking for participants. This trial was first announced on June 17th, 2022 and the most recent update was October 5th of the same year."

Answered by AI

Do patients often experience negative side effects from Paltusotine?

"This is a Phase 2 trial, which means that while there are some data supporting safety, none of the available information suggests efficacy. Our team scores it as a 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome

2022. "Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05361668.

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