Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

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.

Official Title

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

Keywords

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, Neuroendocrine tumor, Paltusotine, CRN00808, Lanreotide, Octreotide, Somatostatin agonist, Neoplasms, Malignant Carcinoid Syndrome, Pancreatic Neoplasms, Syndrome, Diarrhea, Serotonin Syndrome, Randomized: 40 mg Paltusotine, Randomized: 80 mg Paltusotine

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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

Locations

  • Crinetics Study Site
    Los Angeles California 90095 United States
  • Crinetics Study Site
    Los Angeles California 90048 United States
  • Crinetics Study Site
    Newport Beach California 92663 United States
  • Crinetics Study Site
    Stanford California 94305 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Crinetics Pharmaceuticals Inc.
Links
To obtain contact information for a study center near you, click here.
ID
NCT05361668
Phase
Phase 2 research study
Study Type
Interventional
Participants
About 36 people participating
Last Updated