NCT05361668CompletedPhase 2
Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome
A Randomized, Parallel Group Study to Evaluate the Safety, Pharmacokinetics, and Dose Response of Paltusotine Treatment in Subjects With Carcinoid Syndrome
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 27 Apr 2022
- Start date
- 22 Apr 2022
- Primary completion date
- 7 Mar 2024
- Lead sponsor
- Crinetics Pharmaceuticals Inc.
- NCT number
- NCT05361668
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 36
- From 22 Apr 2022 to the primary completion date, 7 Mar 2024
- 27 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Diarrhea attributed to any condition(s) other than carcinoid syndrome.
- Requires second line treatments (eg, telotristat) for control of carcinoid syndrome symptoms.
Other
- Uncontrolled/severe diarrhea associated with significant volume contraction, dehydration, or hypotension.
Who the study is looking for
- 1\. 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (27)
Sites in registry order. Save your city in your profile to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.