Study on Daily Oral Paltusotine for Treating Carcinoid Syndrome
Sponsor: Crinetics Pharmaceuticals Inc.
ClinicalTrials ID:NCT07087054
This clinical trial is testing the effectiveness and safety of a daily oral medication called paltusotine for adults with carcinoid syndrome, a condition caused by certain types of tumors. The study will compare paltusotine to a placebo and also look at its long-term safety.
Patient Parameters
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Program Overview
The study aims to find out if paltusotine, taken as a daily pill, can help manage symptoms of carcinoid syndrome in adults with specific types of neuroendocrine tumors. It will compare the effects of paltusotine to a placebo and assess its safety over a long period.
Description
This global study is designed to test the effectiveness and safety of paltusotine, a daily oral medication, in adults with carcinoid syndrome. The study is divided into several phases: an initial screening period of up to 11 weeks, a 16-week period where participants are randomly assigned to receive either paltusotine or a placebo without knowing which one they are taking, a longer open-label phase lasting 104 weeks where all participants receive paltusotine, and a final follow-up period of 4 weeks. The goal is to see if paltusotine can effectively manage symptoms like flushing and bowel movement changes in people with carcinoid syndrome.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older.
- Willing to follow study procedures, including keeping a study diary.
- Diagnosed with carcinoid syndrome and needing medical treatment, showing symptoms like flushing.
- If not currently on certain treatments, must have more than one flushing episode per day over 14 days.
- If stopping certain treatments, must show an increase in flushing episodes during a washout period.
- Have confirmed neuroendocrine tumors that are locally advanced or have spread.
- No significant worsening of the disease in the last 6 months.
Exclusion Criteria
- Diarrhea caused by conditions other than carcinoid syndrome.
- Severe diarrhea causing dehydration or low blood pressure.
- Need for additional treatments for carcinoid syndrome symptoms.
- Recent treatment with specific cancer therapies or major surgery.
- History of another cancer within the last 3 years, except for certain skin or in situ cancers.
- Diabetes treated with insulin for less than 6 weeks or poorly controlled diabetes.
- Inability to use certain injections or lack of response to similar treatments.
- Other significant health issues not related to carcinoid syndrome.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Hoag Memorial Hospital Presbyterian | 92663 | Newport Beach | California |
| Yale University - New Haven Hospital - Yale Cancer Center | 06510 | New Haven | Connecticut |
| Winshop Cancer Institute - Emory University | 30322 | Atlanta | Georgia |
| University of Kentucky Medical Center | 40536 | Lexington | Kentucky |
| Louisiana State University Health Sciences | 70006 | Metairie | Louisiana |
| Henry Ford Cancer - Detroit | 48202 | Detroit | Michigan |
| Mayo Clinic | 55905 | Rochester | New York |
| University Hospitals Cleveland Medical Center | 44106 | Cleveland | Ohio |
| Hospital of the University of Pennsylvania | 19104 | Philadelphia | Pennsylvania |
| University of Virginia Comprehensive Cancer Center | 22903 | Charlottesville | Virginia |
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