RECRUITING

Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen

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Conditions

Carcinoid SyndromeCarcinoidCarcinoid TumorCarcinoid Tumor of IleumCarcinoid Tumor of CecumCarcinoid Tumor of LiverCarcinoid Tumor of PancreasCarcinoid Syndrome DiarrheaCarcinoid Intestine TumorNeuroendocrine tumorPaltusotineCRN00808LanreotideOctreotideSomatostatin agonist

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A Phase 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of paltusotine treatment vs placebo as well as the long-term safety of paltusotine in adults with carcinoid syndrome due to well-differentiated neuroendocrine tumors. The purpose of this study is to continue the evaluation of the safety, efficacy, and pharmacokinetics (PK) of paltusotine in participants with carcinoid syndrome.

Official Title

A Randomized, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Paltusotine in Adults With Carcinoid Syndrome Due to Well-Differentiated Neuroendocrine Tumors

Quick Facts

Study Start:2025-08
Study Completion:2030-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07087054

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female ≥18 years of age, at the time of Screening.
  2. * Willing and able to comply with the study procedures as specified in the protocol, including at least 70% compliance with the study diary for the 2-week period.
  3. * Documented carcinoid syndrome requiring medical therapy. Participants must exhibit symptoms of flushing with or without frequent BMs as follows:
  4. * For participants who are naïve/not currently treated with somatostatin receptors ligands (SRL), they must exhibit an average of \>1 flushing episode/day over a period of 14 days
  5. * For participants who will wash out from SRL treatment, they must exhibit an increase in daily average flushing episodes and an average of \>1 flushing episode/day over a period of 14 days during the Washout Period.
  6. * Evaluable documentation of locally advanced or metastatic histopathologically confirmed well-differentiated neuroendocrine tumor(s) \[NETs\].
  7. * No significant disease progression as assessed by the Investigator within the last 6 months before randomization.
  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 in the opinion of the Investigator.
  4. * Treatment with specific NET 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. * Major surgery within 8 weeks before Screening.
  6. * History of another primary malignancy \<3 years prior to the date of randomization, except for adequately treated basal or squamous cell carcinoma of the skin, cancer of the breast or cervix in situ, previously treated malignancy, if all treatment for that malignancy was completed at least 3 years prior to first dose of study treatment, and no current evidence of disease, concurrent malignancy determined to be clinically stable and not requiring treatment.
  7. * Diabetes mellitus treated with insulin for less than 6 weeks prior to the study entry.
  8. * Poorly controlled diabetes mellitus defined as having a hemoglobin A1c (HbA1c) ≥8.5%
  9. * Unable to administer short-acting (SA) octreotide (octreotide acetate injection), or prior nonresponse documented with somatostatin agonists.
  10. * Clinically significant concomitant disease or indicator of disease that is not a result of the primary disease under study, including but not limited to cardiovascular disease, estimated glomerular filtration rate 2×upper limit of normal \[ULN\], and/or total bilirubin (TB) \>1.5×ULN. (Participants with previously diagnosed Gilbert's syndrome not accompanied by other hepatobiliary disorders and associated with TB

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
United States
Louisiana State University Health Sciences
Metairie, Louisiana, 70006
United States

Collaborators and Investigators

Sponsor: Crinetics Pharmaceuticals Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08
Study Completion Date2030-01

Study Record Updates

Study Start Date2025-08
Study Completion Date2030-01

Terms related to this study

Keywords Provided by Researchers

  • Neuroendocrine tumor
  • Paltusotine
  • CRN00808
  • Carcinoid syndrome
  • Lanreotide
  • Octreotide
  • Somatostatin agonist

Additional Relevant MeSH Terms

  • Carcinoid Syndrome
  • Carcinoid
  • Carcinoid Tumor
  • Carcinoid Tumor of Ileum
  • Carcinoid Tumor of Cecum
  • Carcinoid Tumor of Liver
  • Carcinoid Tumor of Pancreas
  • Carcinoid Syndrome Diarrhea
  • Carcinoid Intestine Tumor