Paltusotine for Carcinoid Syndrome

Recruiting at 27 trial locations

Overseen By Crinetics Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Crinetics Pharmaceuticals Inc.

Must be taking: Somatostatin receptor ligands

Must not be taking: Telotristat, Everolimus, Sunitinib

Disqualifiers: Uncontrolled diarrhea, Recent malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

36 Participants Needed

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are currently treated with certain medications like lanreotide or octreotide and are symptomatically controlled, you may continue with them. If you are on other specific NET tumor therapies, you may need to stop them at least 4 to 12 weeks before screening.

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 taking lanreotide or octreotide and my symptoms are under control.

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

My condition hasn't worsened significantly in the last 6 months.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomized Treatment

Participants receive paltusotine treatment to evaluate safety, pharmacokinetics, and dose response

8 weeks

Open-Label Extension

Participants may opt into continuation of treatment long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Paltusotine

Trial Overview 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.

Participant Groups

Group I: 80 mg Paltusotine Experimental Treatment 1 Intervention

Group II: 40 mg Paltusotine Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Crinetics Pharmaceuticals Inc.

Lead Sponsor

Trials

13

Recruited

760+