Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen
Recruiting
Phase 3
Interventional Study
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
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 141 (estimated)
- Sponsor
- Crinetics Pharmaceuticals Inc. · Industry
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About This Trial
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 particip…
Trial Locations
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Eligibility 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 thera…
Contacts