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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

June 17, 2022

Primary Completion Date

April 30, 2024

Study Completion Date

February 28, 2026

Conditions
Carcinoid SyndromeCarcinoidCarcinoid TumorCarcinoid Tumor of IleumCarcinoid Tumor of CecumCarcinoid Syndrome DiarrheaCarcinoid Intestine TumorCarcinoid Tumor of LiverCarcinoid Tumor of Pancreas
Interventions
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)

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)

Trial Locations (35)

10029

Crinetics Study Site, New York

11794

Crinetics Study Site, Stony Brook

15036

Crinetics Study Site Peru #1, Lima

Crinetics Study Site Peru #2, Lima

33136

Crinetics Study Site, Miami

40506

Crinetics Study Site, Lexington

43210

Crinetics Study Site, Columbus

44106

Crinetics Study Site, Cleveland

52242

Crinetics Study Site, Iowa City

55905

Crinetics Study Site, Rochester

70112

Crinetics Study Site, New Orleans

76000

Crinetics Study Site, Querétaro City

76070

Crinetics Study Site, Querétaro City

77030

Crinetics Study Site, Houston

90048

Crinetics Study Site, Los Angeles

90095

Crinetics Study Site, Los Angeles

92663

Crinetics Study Site, Newport Beach

94305

Crinetics Study Site, Stanford

88811508

Crinetics Study Site, Criciúma

02118

Crinetics Study Site, Boston

C1180 AAX

Crinetics Study Site, CABA

C1264AAA

Crinetics Study Site, CABA

C1426ANZ

Crinetics Study Site, CABA

C1017AAS

Crinetics Study Site, CABA

C1425BGH

Crinetics Study Site, CABA

60430-275

Crinetics Study Site, Fortaleza

20231-092

Crinetics Study Site, Rio de Janeiro

22061-080

Crinetics Study Site, Rio de Janeiro

22281-100

Crinetics Study Site, Rio de Janeiro

01509-010

Crinetics Study Site, São Paulo

M4N 3M5

Crinetics Study Site, Toronto

06100

Crinetics Study Site, Mexico City

40-514

Crinetics Study Site, Katowice

02-351

Crinetics Study Site, Warsaw

53-413

Crinetics Study Site, Wroclaw

Sponsors
All Listed Sponsors
lead

Crinetics Pharmaceuticals Inc.

INDUSTRY

NCT05361668 - Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome | Biotech Hunter | Biotech Hunter