Primary outcomeNumber· First dose of investigational medicine to End of Randomized Treatment Phase (8 weeks)
Safety - Incidence of Treatment-emergent Adverse Events (TEAEs)
| Group | Value (participants) |
|---|---|
| 40 mg Paltusotine | 16 |
| 80 mg Paltusotine | 15 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataStudy to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome
NCTNCT05361668 (opens ClinicalTrials.gov in a new tab)Other idCRN00808-11
This trial does not test a peptide that PepBank tracks.
- Measures Lanreotide, does not give it. It appears in the eligibility rules.
- Measures Octreotide, does not give it. It appears in the eligibility rules.
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 36 participants (actual)
- Sponsor
- Crinetics Pharmaceuticals Inc. · Industry
- Design
- Randomized · Open label (no masking)
- Countries
7 countries
United States, Argentina, Brazil, Canada, Mexico, Peru, Poland
- Start
- 22 Apr 2022
- Primary completion
- 7 Mar 2024
- Completion
- 24 Feb 2026
- First posted
- 5 May 2022
- Last update posted
- 19 Mar 2026
- Conditions
- 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
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
202220232024202520262027
- Ph 2
Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome
NCT0536166822 Apr 2022 to 24 Feb 2026
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Randomized: 40 mg PaltusotineDrug
- Randomized: 80 mg PaltusotineDrug
Arms2
Experimental
40 mg Paltusotine
Participants received paltusotine 40mg, in tablet form, orally, daily, for 8 weeks.
Experimental
80 mg Paltusotine
Participants received paltusotine 80mg, in tablet form, orally, daily for 8 weeks.
Primary outcomes1
Outcomes the sponsor listed as primary.
Safety - Incidence of Treatment-emergent Adverse Events (TEAEs)
Time frame · First dose of investigational medicine to End of Randomized Treatment Phase (8 weeks)
Registry description
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(1)
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])
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(1)
Secondary outcomeGeometric mean· Measured at each visit (pre and post dose) up to Week 8 (i.e., End of Randomized Treatment Phase [EOR])
Pharmacokinetics (PK) of Paltusotine
| Group | Value (ng/mL) | Spread |
|---|---|---|
| 40 mg Paltusotine | 188 | 80.8 |
| 80 mg Paltusotine | 360 | 103.3 |
| 120 mg Paltusotine | not posted | – |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| 40 mg PaltusotineRandomized: 40 mg paltusotine: Two 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 80 mg) | 0 / 18 | 2 / 18 | 16 / 18 |
| 80 mg PaltusotineRandomized: 80 mg paltusotine: Four 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 120 mg) | 1 / 18 | 2 / 18 | 15 / 18 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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.
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