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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05361668
Recruitment Status : Active, not recruiting
First Posted : May 5, 2022
Last Update Posted : February 1, 2024
Sponsor:
Information provided by (Responsible Party):
Crinetics Pharmaceuticals Inc.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 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 : June 17, 2022
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : February 2026


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)




Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Baseline to End of Randomized Treatment Phase (8 weeks) ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK) of paltusotine [ Time Frame: Measured at Week 8 ]
    Steady state trough levels at each dose at End of Randomized Treatment Phase (EOR)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05361668


Locations
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United States, California
Crinetics Study Site
Los Angeles, California, United States, 90048
Crinetics Study Site
Los Angeles, California, United States, 90095
Crinetics Study Site
Newport Beach, California, United States, 92663
Crinetics Study Site
Stanford, California, United States, 94305
United States, Florida
Crinetics Study Site
Miami, Florida, United States, 33136
United States, Iowa
Crinetics Study Site
Iowa City, Iowa, United States, 52242
United States, Kentucky
Crinetics Study Site
Lexington, Kentucky, United States, 40506
United States, Louisiana
Crinetics Study Site
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Crinetics Study Site
Boston, Massachusetts, United States, 02118
United States, Minnesota
Crinetics Study Site
Rochester, Minnesota, United States, 55905
United States, New York
Crinetics Study Site
New York, New York, United States, 10029
Crinetics Study Site
Stony Brook, New York, United States, 11794
United States, Ohio
Crinetics Study Site
Cleveland, Ohio, United States, 44106
Crinetics Study Site
Columbus, Ohio, United States, 43210
United States, Texas
Crinetics Study Site
Houston, Texas, United States, 77030
Argentina
Crinetics Study Site
Caba, Buenos Aires, Argentina, C1180 AAX
Crinetics Study Site
Caba, Buenos Aires, Argentina, C1264AAA
Crinetics Study Site
Caba, Buenos Aires, Argentina, C1426ANZ
Crinetics Study Site
Caba, Argentina, C1017AAS
Crinetics Study Site
Caba, Argentina, C1425BGH
Brazil
Crinetics Study Site
Fortaleza, Ceará, Brazil, 60430-275
Crinetics Study Site
Criciúma, Santa Catarina, Brazil, 88811508
Crinetics Study Site
Rio De Janeiro, Brazil, 20231-092
Crinetics Study Site
Rio De Janeiro, Brazil, 22061-080
Crinetics Study Site
Rio De Janeiro, Brazil, 22281-100
Crinetics Study Site
São Paulo, Brazil, 01509-010
Canada
Crinetics Study Site
Toronto, Canada, M4N 3M5
Mexico
Crinetics Study Site
Mexico City, Cuauhtemoc, Mexico, 06100
Crinetics Study Site
Santiago De Querétaro, Querétaro, Mexico, 76000
Crinetics Study Site
Santiago De Querétaro, Querétaro, Mexico, 76070
Peru
Crinetics Study Site Peru #1
Lima, Peru, 15036
Crinetics Study Site Peru #2
Lima, Peru, 15036
Poland
Crinetics Study Site
Katowice, Poland, 40-514
Crinetics Study Site
Warszawa, Poland, 02-351
Crinetics Study Site
Wrocław, Poland, 53-413
Sponsors and Collaborators
Crinetics Pharmaceuticals Inc.
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Responsible Party: Crinetics Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT05361668    
Other Study ID Numbers: CRN00808-11
First Posted: May 5, 2022    Key Record Dates
Last Update Posted: February 1, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Crinetics Pharmaceuticals Inc.:
Neuroendocrine tumor
Paltusotine
CRN00808
Carcinoid syndrome
Lanreotide
Octreotide
Somatostatin agonist
Additional relevant MeSH terms:
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Neoplasms
Carcinoid Tumor
Malignant Carcinoid Syndrome
Pancreatic Neoplasms
Syndrome
Diarrhea
Serotonin Syndrome
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases