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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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. Any malignancy except for eligible NET, basal cell or squamous cell skin carcinoma
considered clinically cured, or in situ cervical carcinoma.

6. Diabetes mellitus treated with insulin for less than 6 weeks prior to the study entry

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 6/6/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Thorvardur Halfdanarson, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available