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

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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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • Male or female subjects ≥18 years of age.
  • 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.
  • Any malignancy except for eligible NET, basal cell or squamous cell skin carcinoma considered clinically cured, or in situ cervical carcinoma.
  • Diabetes mellitus treated with insulin for less than 6 weeks prior to the study entry

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Study Stats
Protocol No.
22-001576
Category
Other Cancer
Principal Investigator
Randolph Hecht
Contact
Rachel Andes
Location
  • UCLA Santa Monica
For Providers
NCT No.
NCT05361668
For detailed technical eligibility, visit ClinicalTrials.gov.