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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05361668
Other study ID # CRN00808-11
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date June 17, 2022
Est. completion date February 2026

Study information

Verified date January 2024
Source Crinetics Pharmaceuticals Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 36
Est. completion date February 2026
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Male or female subjects =18 years of age. 2. Documented carcinoid syndrome requiring medical therapy. 1. Not currently treated with somatostatin receptor ligands agonists for at least 12 weeks prior to screening and actively symptomatic. This can include treatment-naïve subjects. 2. 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 specific NET tumor therapy <4 weeks before Screening (such as everolimus or sunitinib) or hepatic embolization, radiotherapy, peptide receptor radionuclide therapy (PRRT), and/or tumor debulking <12 weeks before Screening. 5. History of another primary malignancy <3 years prior to the date of first dose, except for adequately treated basal or squamous cell carcinoma of the skin, cancer of the breast or cervix in situ, previously treated or concurrent malignancy determined to be clinically stable and not requiring treatment. 6. Diabetes mellitus treated with insulin for less than 6 weeks prior to the study entry

Study Design


Intervention

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)
Randomized: 80 mg Paltusotine
Four 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 120 mg)

Locations

Country Name City State
Argentina Crinetics Study Site Caba Buenos Aires
Argentina Crinetics Study Site Caba Buenos Aires
Argentina Crinetics Study Site Caba Buenos Aires
Argentina Crinetics Study Site Caba
Argentina Crinetics Study Site Caba
Brazil Crinetics Study Site Criciúma Santa Catarina
Brazil Crinetics Study Site Fortaleza Ceará
Brazil Crinetics Study Site Rio De Janeiro
Brazil Crinetics Study Site Rio De Janeiro
Brazil Crinetics Study Site Rio De Janeiro
Brazil Crinetics Study Site São Paulo
Canada Crinetics Study Site Toronto
Mexico Crinetics Study Site Mexico City Cuauhtemoc
Mexico Crinetics Study Site Santiago De Querétaro Querétaro
Mexico Crinetics Study Site Santiago De Querétaro Querétaro
Peru Crinetics Study Site Peru #1 Lima
Peru Crinetics Study Site Peru #2 Lima
Poland Crinetics Study Site Katowice
Poland Crinetics Study Site Warszawa
Poland Crinetics Study Site Wroclaw
United States Crinetics Study Site Boston Massachusetts
United States Crinetics Study Site Cleveland Ohio
United States Crinetics Study Site Columbus Ohio
United States Crinetics Study Site Houston Texas
United States Crinetics Study Site Iowa City Iowa
United States Crinetics Study Site Lexington Kentucky
United States Crinetics Study Site Los Angeles California
United States Crinetics Study Site Los Angeles California
United States Crinetics Study Site Miami Florida
United States Crinetics Study Site New Orleans Louisiana
United States Crinetics Study Site New York New York
United States Crinetics Study Site Newport Beach California
United States Crinetics Study Site Rochester Minnesota
United States Crinetics Study Site Stanford California
United States Crinetics Study Site Stony Brook New York

Sponsors (1)

Lead Sponsor Collaborator
Crinetics Pharmaceuticals Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  Mexico,  Peru,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of treatment-emergent adverse events (TEAEs) Baseline to End of Randomized Treatment Phase (8 weeks)
Secondary Pharmacokinetics (PK) of paltusotine Steady state trough levels at each dose at End of Randomized Treatment Phase (EOR) Measured at Week 8
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