Trial details
A Randomized, Parallel Group Study to Evaluate the Safety, Pharmacokinetics, and Dose Response of Paltusotine Treatment in Subjects with Carcinoid Syndrome
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Trial short name: CRN00808-11
Official title: A Randomized, Parallel Group Study to Evaluate the Safety, Pharmacokinetics, and Dose Response of Paltusotine Treatment in Subjects with Carcinoid Syndrome
Principal Investigator: Dr. Simron Singh
Cancer type: Neuroendocrine
Cancer location: Neuroendocrine
Disease stage: Early Cancer
Trial phase: Phase 2
Intervention: Drug: Randomized: 40 mg Paltusotine Drug: Randomized: 80 mg Paltusotine
Registration #:
NCT05361668 
Contact e-mail: cancerclinicaltrials@sunnybrook.ca
Trial description:
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and exploratory dose response of paltusotine treatment in subjects with carcinoid syndrome. This study consists of a Randomized Treatment Phase followed by an Open-Label Extension (OLE) Phase.
Inclusion Criteria: 1. Male or female subjects ≥18 years of age. 2. Documented carcinoid syndrome requiring medical therapy. a. Naïve to somatostatin receptor ligands and actively symptomatic or b. Subjects currently treated with lanreotide, octreotide long acting release, or short acting octreotide (subcutaneous or oral) who are currently symptomatically controlled 3. Evaluable documentation of locally advanced or metastatic histopathologically confirmed well-differentiated neuroendocrine tumor (NET). 4. No significant disease progression as assessed by the Investigator within the last 6 months before initiation of study drug dosing. Exclusion Criteria: 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. 4. Treatment with tumor-directed therapy <4 weeks before Screening or hepatic embolization, radiotherapy, peptide receptor radionuclide therapy (PRRT), and/or tumor debulking <12 weeks before Screening. 5. Any malignancy except for eligible NET, basal cell or squamous cell skin carcinoma considered clinically cured, or in situ cervical carcinoma.
