Clinical trial NCT05361668: Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome
Official title: A Randomized, Parallel Group Study to Evaluate the Safety, Pharmacokinetics, and Dose Response of Paltusotine Treatment in Subjects With Carcinoid Syndrome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: 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
Keywords: Neuroendocrine tumor
Paltusotine
CRN00808
Carcinoid syndrome
Lanreotide
Octreotide
Somatostatin agonist
Lead sponsor: Crinetics Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-05
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: Baseline to End of Randomized Treatment Phase (8 weeks)
Secondary outcomes:
measure: Pharmacokinetics (PK) of paltusotine
timeFrame: Measured at Week 8
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Crinetics Study Site
state: California
city: Los Angeles
country: United States
facility: Crinetics Study Site
state: California
city: Newport Beach
country: United States
facility: Crinetics Study Site
state: California
city: Stanford
country: United States
facility: Crinetics Study Site
state: California
city: Miami
country: United States
facility: Crinetics Study Site
state: Florida
city: Iowa City
country: United States
facility: Crinetics Study Site
state: Iowa
city: Lexington
country: United States
facility: Crinetics Study Site
state: Kentucky
city: New Orleans
country: United States
facility: Crinetics Study Site
state: Louisiana
city: Boston
country: United States
facility: Crinetics Study Site
state: Massachusetts
city: Rochester
country: United States
facility: Crinetics Study Site
state: Minnesota
city: New York
country: United States
facility: Crinetics Study Site
state: New York
city: Stony Brook
country: United States
facility: Crinetics Study Site
state: New York
city: Cleveland
country: United States
facility: Crinetics Study Site
state: Ohio
city: Columbus
country: United States
facility: Crinetics Study Site
state: Ohio
city: Houston
country: United States
facility: Crinetics Study Site
state: Texas
city: Caba
country: Argentina
facility: Crinetics Study Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Crinetics Study Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Crinetics Study Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Crinetics Study Site
city: Caba
country: Argentina
facility: Crinetics Study Site
city: Fortaleza
country: Brazil
facility: Crinetics Study Site
state: Ceará
city: Criciúma
country: Brazil
facility: Crinetics Study Site
state: Santa Catarina
city: Rio De Janeiro
country: Brazil
facility: Crinetics Study Site
city: Rio De Janeiro
country: Brazil
facility: Crinetics Study Site
city: Rio De Janeiro
country: Brazil
facility: Crinetics Study Site
city: São Paulo
country: Brazil
facility: Crinetics Study Site
city: Toronto
country: Canada
facility: Crinetics Study Site
city: Mexico City
country: Mexico
facility: Crinetics Study Site
state: Cuauhtemoc
city: Santiago De Querétaro
country: Mexico
facility: Crinetics Study Site
state: Querétaro
city: Santiago De Querétaro
country: Mexico
facility: Crinetics Study Site
state: Querétaro
city: Lima
country: Peru
facility: Crinetics Study Site Peru #1
city: Lima
country: Peru
facility: Crinetics Study Site Peru #2
city: Katowice
country: Poland
facility: Crinetics Study Site
city: Warszawa
country: Poland
facility: Crinetics Study Site
city: Wrocław
country: Poland
facility: Crinetics Study Site
Study officials:
References: