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NCT07087054 | RECRUITING | Carcinoid Syndrome

Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen
Sponsor:

Crinetics Pharmaceuticals Inc.

Brief Summary:

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.

Condition or disease

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

Intervention/treatment

Paltusotine

Placebo

Phase

PHASE3

Detailed Description:

This is a global, randomized, parallel-group, placebo-controlled study to evaluate the efficacy and safety of paltusotine in adults with carcinoid syndrome. The study includes a screening period of up to 11 weeks, a double-blinded randomized control period of 16 weeks, an open label extension period of 104 weeks, and a follow-up period of 4 weeks.

Study Type : INTERVENTIONAL
Estimated Enrollment : 141 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-10
Estimated Primary Completion Date : 2027-08
Estimated Study Completion Date : 2030-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Male or female ≥18 years of age, at the time of Screening.
  • * 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.
  • * Documented carcinoid syndrome requiring medical therapy. Participants must exhibit symptoms of flushing with or without frequent BMs as follows
    • * 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
    • * 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.
    • * Evaluable documentation of locally advanced or metastatic histopathologically confirmed well-differentiated neuroendocrine tumor(s) \[NETs\].
    • * No significant disease progression as assessed by the Investigator within the last 6 months before randomization.
    Exclusion Criteria
    • * Diarrhea attributed to any condition(s) other than carcinoid syndrome.
    • * Uncontrolled/severe diarrhea associated with significant volume contraction, dehydration, or hypotension.
    • * Requires second line treatments (eg, telotristat) for control of carcinoid syndrome symptoms in the opinion of the Investigator.
    • * 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.
    • * Major surgery within 8 weeks before Screening.
    • * 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.
    • * Diabetes mellitus treated with insulin for less than 6 weeks prior to the study entry.
    • * Poorly controlled diabetes mellitus defined as having a hemoglobin A1c (HbA1c) ≥8.5%
    • * Unable to administer short-acting (SA) octreotide (octreotide acetate injection), or prior nonresponse documented with somatostatin agonists.
    • * 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
Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen

Location Details

NCT07087054

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States, 92663

RECRUITING

United States, Connecticut

Yale University - New Haven Hospital - Yale Cancer Center

New Haven, Connecticut, United States, 06510

RECRUITING

United States, Georgia

Winshop Cancer Institute - Emory University

Atlanta, Georgia, United States, 30322

RECRUITING

United States, Kentucky

University of Kentucky Medical Center

Lexington, Kentucky, United States, 40536

RECRUITING

United States, Louisiana

Louisiana State University Health Sciences

Metairie, Louisiana, United States, 70006

RECRUITING

United States, Road cancer

Henry Ford Cancer - Detroit

Detroit, Road cancer, United States, 48202

RECRUITING

United States, Virginia

University of Virginia Comprehensive Cancer Center

Charlottesville, Virginia, United States, 22903

RECRUITING

Argentina,

Guemes Sanatorium

Buenos Aires, Argentina, C1180AAX

RECRUITING

Argentina,

Medical Institute of the Clinical Studies Foundation

Santa Fe, Argentina, 2000

RECRUITING

Brazil, Brazil

AC Camargo Cancer Center

São Paulo, Brazil, Brazil, 01509-010