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

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Trial ID: NCT05361668

Purpose

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.

Official Title

A Randomized, Parallel Group Study to Evaluate the Safety, Pharmacokinetics, and Dose Response of Paltusotine Treatment in Subjects With Carcinoid Syndrome

Stanford Investigator(s)

Shagufta Shaheen
Shagufta Shaheen

Clinical Assistant Professor, Medicine - Oncology

Eligibility


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

Intervention(s):

drug: Randomized: 40 mg Paltusotine

drug: Randomized: 80 mg Paltusotine

Recruiting

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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
gitrialeligibility@stanford.edu
(650) 498-7757

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