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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Male or female subjects ≥18 years of age. 2. Documented carcinoid syndrome requiring medical therapy. 1. Naïve to somatostatin receptor ligands and actively symptomatic or 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.

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 tumor-directed therapy <4 weeks before Screening or hepatic embolization, radiotherapy, peptide receptor radionuclide therapy (PRRT), and/or tumor debulking <12 weeks before Screening. 5. Any malignancy except for eligible NET, basal cell or squamous cell skin carcinoma considered clinically cured, or in situ cervical carcinoma.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
40 mg Paltusotine
  • 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)
Experimental
80 mg Paltusotine
  • 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)

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40506

More Details

NCT ID
NCT05361668
Status
Recruiting
Sponsor
Crinetics Pharmaceuticals Inc.

Study Contact

Crinetics Clinical Trials
833-827-9741
clinicaltrials@crinetics.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.