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

Phase 2

Active, not recruiting

• Conditions: Carcinoid Syndrome; Carcinoid Tumor of Ileum; Carcinoid Intestine Tumor; Carcinoid Tumor of Liver; Carcinoid Tumor; Carcinoid Tumor of Cecum; Carcinoid Syndrome Diarrhea; Carcinoid Tumor of Pancreas; Carcinoid

• Registration Number: NCT05361668
• Lead Sponsor: Crinetics Pharmaceuticals Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-27
• Study First Submitted QC: 2022-05-02
• Study First Posted: 2022-05-05
• Study Start: 2022-06-17
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01
• Primary Completion: 2024-04
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 36

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).

4. No significant disease progression as assessed by the Investigator within the last 6 months before initiation of study drug dosing.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events (TEAEs)	Baseline to End of Randomized Treatment Phase (8 weeks)

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) of paltusotine	Measured at Week 8	Steady state trough levels at each dose at End of Randomized Treatment Phase (EOR)

Trial Locations

Locations (3)

Crinetics Study Site Peru #2; 🇵🇪 Lima, Peru

Crinetics Study Site; 🇵🇱 Wrocław, Poland

Crinetics Study Site Peru #1; 🇵🇪 Lima, Peru