Phase 2
N=36
Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome
Carcinoid Syndrome · Carcinoid · Carcinoid Tumor · Carcinoid Tumor of Ileum · Carcinoid Tumor of Cecum
Bottom Line
View on ClinicalTrials.gov: NCT05361668 ↗Enrolled (actual)
36
Serious AEs
11.1%
Results posted
Oct 2025
Primary outcome: Primary: Safety - Incidence of Treatment-emergent Adverse Events (TEAEs) — 16; 15; 10; 9 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Randomized: 40 mg Paltusotine (Drug); Randomized: 80 mg Paltusotine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Crinetics Pharmaceuticals Inc.
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety - Incidence of Treatment-emergent Adverse Events (TEAEs) |
16; 15; 10; 9; 3; 1 | — |
| SECONDARY Pharmacokinetics (PK) of Paltusotine |
188; 360; 61.4; 193; 217; 473 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05361668). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.