Current partner codePEPTIDESDE
NCT05361668·Phase 2·INTERVENTIONAL

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

Status

Completed

Phase

Phase 2

Enrollment

36

Locations

35

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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.

Full detailed description

This is a Phase 2, randomized, open-label, parallel-group, multicenter study designed to evaluate the safety, pharmacokinetics, and efficacy of paltusotine treatment in subjects with carcinoid syndrome. The study was conducted in 2 parts: a Randomized Treatment Phase (RTP) which is completed, and an Open-label Extension (OLE) Phase which is still ongoing. The RTP consisted of paltusotine treatment for 8 weeks. Subjects who completed the RTP were eligible to enter the OLE Phase at the recommendation of the Investigator. In the ongoing OLE Phase, paltusotine is being administered for a further 102 weeks. The total duration of paltusotine treatment for the combined RTP and OLE Phase is up to 110 weeks (28 months).

Interventions

Treatment arms and agents.

DRUG

Randomized: 40 mg Paltusotine

Two 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 80 mg)

DRUG

Randomized: 80 mg Paltusotine

Four 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 120 mg)

Timeline

From registration to results.

  1. First posted

    May 5, 2022

  2. Study start

    Apr 22, 2022

  3. Primary completion

    Mar 7, 2024

  4. Study completion

    Feb 24, 2026

  5. Results posted

    Oct 31, 2025

  6. Registry updated

    Mar 19, 2026

Outcomes

What the study measures.

Primary outcomes

Safety - Incidence of Treatment-emergent Adverse Events (TEAEs)

Time frame · First dose of investigational medicine to End of Randomized Treatment Phase (8 weeks)

Incidence of TEAEs, including serious TEAEs and TEAEs leading to discontinuation; change from baseline to the EOR in safety parameters: clinical laboratory tests, physical exam findings, vital signs, 12-lead ECG, and 24-hour continuous cardiac monitoring (only for subjects on 120 mg dose). In addition to all-cause mortality, deaths were categorized by primary cause (e.g., cardiovascular) based on medical adjudication. Events were coded using MedDRA and summarized by treatment group, system organ class, and preferred term. TEAEs were reported per randomized arm. There were 2 randomized arms (40 mg and 80 mg paltusotine, with up-or down-dose titration permitted for symptom control). Results are analyzed based on the initially assigned randomization arm, regardless of the actual dose received.

Secondary outcomes

Pharmacokinetics (PK) of Paltusotine

Time frame · Measured at each visit (pre and post dose) up to Week 8 (i.e., End of Randomized Treatment Phase [EOR])

Steady state trough levels by dose and visit for Randomized Treatment Phase (RTP). The "Overall Number of Participants Analyzed" displayed at the top of the PK summary table represents the total number of participants who received each dose at any point during the trial, factoring in dose titrations. PK results are summarized by actual dose taken right before the time of sample collection, rather than by randomized dose. Participants may be included in different dose groups for different visits due to dose titration.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: 1\. Male or female subjects ≥18 years of age. 2. Documented carcinoid syndrome requiring medical therapy. 1. 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. 2. Subjects currently treated with lanreotide, octreotide long acting release, or short acting octreotide (subcutaneous or oral) who are currently symptomatically controlled 3. 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. 4. No significant disease progression as assessed by the Investigator within the last 6 months before initiation of study drug dosing. Exclusion Criteria: 1. Diarrhea attributed to any condition(s) other than carcinoid syndrome. 2. Uncontrolled/severe diarrhea associated with significant volume contraction, dehydration, or hypotension. 3. Requires second line treatments (eg, telotristat) for control of carcinoid syndrome symptoms. 4. 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. 5. 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. 6. Diabetes mellitus treated with insulin for less than 6 weeks prior to the study entry.

Study locations

35 registered sites.

Argentina · Brazil · Canada · Mexico · Peru · Poland · United States. Showing up to 24 locations stored in the fast local snapshot.

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

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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