Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome

Sponsor

Crinetics Pharmaceuticals Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05361668

Collaborator

(none)

Enrollment

Locations

Arms

28.5

Anticipated Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoid Syndrome Carcinoid Carcinoid Tumor Carcinoid Tumor of Ileum Carcinoid Tumor of Cecum Carcinoid Syndrome Diarrhea Carcinoid Intestine Tumor Carcinoid Tumor of Liver Carcinoid Tumor of Pancreas	Drug: Randomized: 40 mg Paltusotine Drug: Randomized: 80 mg Paltusotine	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized, Parallel Group Study to Evaluate the Safety, Pharmacokinetics, and Dose Response of Paltusotine Treatment in Subjects With Carcinoid Syndrome

Actual Study Start Date :

Jun 17, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 40 mg Paltusotine	Drug: Randomized: 40 mg Paltusotine Two 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 80 mg)
Experimental: 80 mg Paltusotine	Drug: Randomized: 80 mg Paltusotine Four 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 120 mg)

Arm

Intervention/Treatment

Experimental: 40 mg Paltusotine

Drug: Randomized: 40 mg Paltusotine

Two 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 80 mg)

Experimental: 80 mg Paltusotine

Drug: Randomized: 80 mg Paltusotine

Four 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 120 mg)

Outcome Measures

Primary Outcome Measures

Incidence of treatment-emergent adverse events (TEAEs) [Baseline to End of Randomized Treatment Phase (8 weeks)]

Secondary Outcome Measures

Pharmacokinetics (PK) of paltusotine [Measured at Week 8]
Steady state trough levels at each dose at End of Randomized Treatment Phase (EOR)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female subjects ≥18 years of age.
Documented carcinoid syndrome requiring medical therapy.
Naïve to somatostatin receptor ligands and actively symptomatic or
Subjects currently treated with lanreotide, octreotide long acting release, or short acting octreotide (subcutaneous or oral) who are currently symptomatically controlled
Evaluable documentation of locally advanced or metastatic histopathologically confirmed well-differentiated neuroendocrine tumor (NET).
No significant disease progression as assessed by the Investigator within the last 6 months before initiation of study drug dosing.

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.
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.
Any malignancy except for eligible NET, basal cell or squamous cell skin carcinoma considered clinically cured, or in situ cervical carcinoma.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Crinetics Study Site	Newport Beach	California	United States	92663
2	Crinetics Study Site	Lexington	Kentucky	United States	40506
3	Crinetics Study Site	Stony Brook	New York	United States	11794