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

Completed · Phase 2

Conditions studied: Carcinoid Syndrome, Carcinoid, Carcinoid Tumor, Carcinoid Tumor of Ileum, Carcinoid Tumor of Cecum, Carcinoid Syndrome Diarrhea, Carcinoid Intestine Tumor, Carcinoid Tumor of Liver, Carcinoid Tumor of Pancreas

In brief

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and exploratory dose response of paltusotine treatment in subjects with carcinoid syndrome. This study consists of a Randomized Treatment Phase followed by an Open-Label Extension (OLE) Phase.

Key facts

Study ID

NCT05361668

Run by

Crinetics Pharmaceuticals Inc.

People needed

36

Starts

2022-04-22

Expected to finish

2026-02-24

Last updated by the study team

2026-03-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects ≥18 years of age. 2. Documented carcinoid syndrome requiring medical therapy.
• Not currently treated with somatostatin receptor ligands agonists for at least 12 weeks prior to screening and actively symptomatic. This can include treatment-naïve subjects.
• Subjects currently treated with lanreotide, octreotide long acting release, or short acting octreotide (subcutaneous or oral) who are currently symptomatically controlled
• Evaluable documentation of locally advanced or metastatic histopathologically confirmed well-differentiated neuroendocrine tumor (NET). Tumors must be Grade 1 (Ki-67 index < 3%, or a mitotic count of < 2 mitoses per 10 high-power fields, if the Ki-67 index is not available) or Grade 2 (Ki-67 index 3-20%, or a mitotic count of 2-20 mitoses per 10 high-power fields, if the Ki-67 index is not available) per the World Health Organization neuroendocrine neoplasm classification (Rindi and Inzani, 2020). Grade 3 tumors are not eligible.
• No significant disease progression as assessed by the Investigator within the last 6 months before initiation of study drug dosing.

You may not qualify if…

• Diarrhea attributed to any condition(s) other than carcinoid syndrome.
• Uncontrolled/severe diarrhea associated with significant volume contraction, dehydration, or hypotension.
• Requires second line treatments (eg, telotristat) for control of carcinoid syndrome symptoms.
• Treatment with specific NET tumor therapy <4 weeks before Screening (such as everolimus or sunitinib) or hepatic embolization, radiotherapy, peptide receptor radionuclide therapy (PRRT), and/or tumor debulking <12 weeks before Screening.
• History of another primary malignancy <3 years prior to the date of first dose, except for adequately treated basal or squamous cell carcinoma of the skin, cancer of the breast or cervix in situ, previously treated or concurrent malignancy determined to be clinically stable and not requiring treatment.
• Diabetes mellitus treated with insulin for less than 6 weeks prior to the study entry.

Where it is running

• Crinetics Study Site — Los Angeles, California, United States
• Crinetics Study Site — Los Angeles, California, United States
• Crinetics Study Site — Newport Beach, California, United States
• Crinetics Study Site — Stanford, California, United States
• Crinetics Study Site — Miami, Florida, United States
• Crinetics Study Site — Iowa City, Iowa, United States
• Crinetics Study Site — Lexington, Kentucky, United States
• Crinetics Study Site — New Orleans, Louisiana, United States
• Crinetics Study Site — Boston, Massachusetts, United States
• Crinetics Study Site — Rochester, Minnesota, United States
• Crinetics Study Site — New York, New York, United States
• Crinetics Study Site — Stony Brook, New York, United States
• Crinetics Study Site — Cleveland, Ohio, United States
• Crinetics Study Site — Columbus, Ohio, United States
• Crinetics Study Site — Houston, Texas, United States
• Crinetics Study Site — CABA, Buenos Aires, Argentina
• Crinetics Study Site — CABA, Buenos Aires, Argentina
• Crinetics Study Site — CABA, Buenos Aires, Argentina
• Crinetics Study Site — CABA, Argentina
• Crinetics Study Site — CABA, Argentina
• Crinetics Study Site — Fortaleza, Ceará, Brazil
• Crinetics Study Site — Rio de Janeiro, Rio de Janeiro, Brazil
• Crinetics Study Site — Rio de Janeiro, Rio de Janeiro, Brazil
• Crinetics Study Site — Criciúma, Santa Catarina, Brazil
• Crinetics Study Site — São Paulo, São Paulo, Brazil

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.