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

• ClinicalTrials.gov Identifier: NCT05361668
• Recruitment Status: Active, not recruiting
• First Posted: May 5, 2022
• Last Update Posted: February 1, 2024
• Sponsor: Crinetics Pharmaceuticals Inc.
• Information provided by (Responsible Party): Crinetics Pharmaceuticals Inc.

Tracking Information

• First Submitted Date: April 27, 2022
• First Posted Date: May 5, 2022
• Last Update Posted Date: February 1, 2024
• Actual Study Start Date: June 17, 2022
• Estimated Primary Completion Date: April 2024 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 2, 2022): Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Baseline to End of Randomized Treatment Phase (8 weeks) ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 2, 2022)

Pharmacokinetics (PK) of paltusotine [ Time Frame: Measured at Week 8 ]

Steady state trough levels at each dose at End of Randomized Treatment Phase (EOR)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• 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

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)
• 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)

Study Arms

• Experimental: 40 mg Paltusotine
  Intervention: Drug: Randomized: 40 mg Paltusotine
• Experimental: 80 mg Paltusotine
  Intervention: Drug: Randomized: 80 mg Paltusotine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: January 31, 2024): 36
• Original Estimated Enrollment (submitted: May 2, 2022): 30
• Estimated Study Completion Date: February 2026
• Estimated Primary Completion Date: April 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Brazil, Canada, Mexico, Peru, Poland, United States

Administrative Information

• NCT Number: NCT05361668
• Other Study ID Numbers: CRN00808-11
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Crinetics Pharmaceuticals Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Crinetics Pharmaceuticals Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Crinetics Pharmaceuticals Inc.
• Verification Date: January 2024