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

Carcinoid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05361668
• Other study ID #: CRN00808-11
• Status: Active, not recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Carcinoid
• Carcinoid Syndrome
• Carcinoid Tumor
• Diarrhea
• Malignant Carcinoid Syndrome
• Neoplasms
• Pancreatic Neoplasms
• Serotonin Syndrome
• Syndrome

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

External Links

•   To obtain contact information for a study center near you, click here.