Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome
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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 |
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Recruitment Status :
Active, not recruiting
First Posted : May 5, 2022
Last Update Posted : February 1, 2024
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Sponsor:
Crinetics Pharmaceuticals Inc.
Information provided by (Responsible Party):
Crinetics Pharmaceuticals Inc.
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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 |
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Carcinoid Tumors
| 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 :
- Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Baseline to End of Randomized Treatment Phase (8 weeks) ]
Secondary Outcome Measures :
- 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:
- Male or female subjects ≥18 years of age.
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Documented carcinoid syndrome requiring medical therapy.
- 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.
- Subjects currently treated with lanreotide, octreotide long acting release, or short acting octreotide (subcutaneous or oral) who are currently symptomatically controlled
- Evaluable documentation of locally advanced or metastatic histopathologically confirmed well-differentiated neuroendocrine tumor (NET).
- No significant disease progression as assessed by the Investigator within the last 6 months before initiation of study drug dosing.
Exclusion Criteria:
- Diarrhea attributed to any condition(s) other than carcinoid syndrome.
- Uncontrolled/severe diarrhea associated with significant volume contraction, dehydration, or hypotension.
- Requires second line treatments (eg, telotristat) for control of carcinoid syndrome symptoms.
- 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.
- 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.
- 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
| 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.
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Crinetics Pharmaceuticals Inc.:
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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 |