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Purpose

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.

Conditions

Eligibility

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

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Paltusotine 80 mg daily
  • Drug: Paltusotine
    Experimental Drug: Randomized
Placebo Comparator
Placebo
  • Drug: Placebo
    Matching Placebo Drug: Randomized

Recruiting Locations

Banner MD Anderson Cancer Center
Gilbert 5295903, Arizona 5551752 85234

Hoag Memorial Hospital Presbyterian
Newport Beach 5376890, California 5332921 92663

Yale University - New Haven Hospital - Yale Cancer Center
New Haven 4839366, Connecticut 4831725 06510

Moffitt Cancer Center
Tampa 4174757, Florida 4155751 33612

Winshop Cancer Institute - Emory University
Atlanta 4180439, Georgia 4197000 30322

University of Iowa Health Care
Iowa City 4862034, Iowa 4862182 52242

University of Kentucky Medical Center
Lexington 4297983, Kentucky 6254925 40536

Louisiana State University Health Sciences
Metairie 4333177, Louisiana 4331987 70006

Henry Ford Cancer - Detroit
Detroit 4990729, Michigan 5001836 48202

Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029

Mayo Clinic
Rochester 5134086, New York 5128638 55905

University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106

Hospital of the University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104

Huntsman Cancer Institute, University of Utah
Salt Lake City 5780993, Utah 5549030 84112

University of Virginia Comprehensive Cancer Center
Charlottesville 4752031, Virginia 6254928 22903

More Details

Status
Recruiting
Sponsor
Crinetics Pharmaceuticals Inc.

Study Contact

Crinetics Clinical Trials
833-276-4636
clinicaltrials@crinetics.com

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.

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.