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

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ClinicalTrials.gov Identifier: NCT05361668
Recruitment Status : Recruiting
First Posted : May 5, 2022
Last Update Posted : October 6, 2022
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
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 Drug: Randomized: 40 mg Paltusotine Drug: Randomized: 80 mg Paltusotine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Parallel Group Study to Evaluate the Safety, Pharmacokinetics, and Dose Response of Paltusotine Treatment in Subjects With Carcinoid Syndrome
Actual Study Start Date : June 17, 2022
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : November 2024

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Baseline to End of Randomized Treatment Phase (8 weeks) ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK) of paltusotine [ Time Frame: Measured at Week 8 ]
    Steady state trough levels at each dose at End of Randomized Treatment Phase (EOR)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05361668

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

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United States, California
Crinetics Study Site Recruiting
Newport Beach, California, United States, 92663
Crinetics Study Site Recruiting
Stanford, California, United States, 94305
United States, Kentucky
Crinetics Study Site Recruiting
Lexington, Kentucky, United States, 40506
United States, New York
Crinetics Study Site Recruiting
Stony Brook, New York, United States, 11794
United States, Texas
Crinetics Study Site Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Crinetics Pharmaceuticals Inc.
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Responsible Party: Crinetics Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT05361668    
Other Study ID Numbers: CRN00808-11
First Posted: May 5, 2022    Key Record Dates
Last Update Posted: October 6, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Crinetics Pharmaceuticals Inc.:
Neuroendocrine tumor
Carcinoid syndrome
Somatostatin agonist
Additional relevant MeSH terms:
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Carcinoid Tumor
Malignant Carcinoid Syndrome
Pancreatic Neoplasms
Serotonin Syndrome
Pathologic Processes
Signs and Symptoms, Digestive
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases