Paltusotine for Carcinoid Syndrome

Recruiting in Palo Alto (17 mi)

+27 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Crinetics Pharmaceuticals Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new medication called paltusotine to see if it is safe and how it behaves in people with carcinoid syndrome. Researchers want to understand how the drug moves through the body and its effects at different doses. The study includes a part where patients receive different treatments and a part where all patients receive paltusotine.

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

I am taking lanreotide or octreotide and my symptoms are under control.

I haven't taken hormone therapy for my symptoms in the last 12 weeks.

+3 more

Exclusion Criteria

I haven't had specific cancer treatments like everolimus or surgery to remove part of the tumor in the last 4 weeks.

I have no cancer except possibly treated skin cancer or cervical cancer.

I have been on insulin for my diabetes for less than 6 weeks.

+3 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Group I: 80 mg PaltusotineExperimental Treatment1 Intervention

Group II: 40 mg PaltusotineExperimental Treatment1 Intervention