Clinical trial

Study of Telotristat (Xermelo) in Combination With Luetetium Lu177 Dotatate (Lutathera) in Well-Differentiated Neuroendocrine Tumors

Name

MCC-20-GI-114-PMC

Description

This trial will test the hypothesis that Telotristat treatment increases the antitumor efficacy of Lutetium Lu 177 Dotatate therapy in neuroendocrine tumors (NETs).

Trial arms

Trial start

2021-09-13

Estimated PCD

2022-06-03

Trial end

2022-06-03

Status

Terminated

Phase

Early phase I

Treatment

Telotristat (Low-Dose)

Participants in this group will receive Lutetium Lu 177 Dotate (Lutathera) by IV every 2 months (Q8weeks) for a total of 4 doses. They will also receive oral Telotristat at 750mg per day (250mg TID) for 20 months.

Arms:

Arm 1: Low-Dose Telotristat

Other names:

Xermelo

Telotristat (High-Dose)

Participants in this group will receive Lutetium Lu 177 Dotate (Lutathera) by IV every 2 months (Q8weeks) for a total of 4 doses. They will also receive oral Telotristat at 1500mg per day (500mg TID) for 20 months.

Arms:

Arm 2: High-Dose Telotristat

Other names:

Xermelo

Size

Primary endpoint

Progression-Free Survival (PFS)

20 months

Eligibility criteria

Inclusion Criteria: * Metastatic, or unresectable, histologically confirmed well-differentiated grade 1 and 2 neuroendocrine tumor with a positive gallium 68 Dotatate scan within 6 months prior to study enrollment * Baseline CT scan or MRI with measurable progressive disease based on RECIST Criteria * Failure of at least one prior systemic cancer treatment for this diagnosis * Recovered from Adverse Events of previously administered therapeutic agents to Grade 2 or less toxicity according to CTCAE version 5.0 * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 * normal organ and marrow function Exclusion Criteria: * Prior exposure to Lutetium Lu 177 Dotatate * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Telotristat or Lutetium Lu 177 Dotatate. * Presence of unstable angina or myocardial infarction * New York Heart Association (NYHA) Class III or IV heart failure * uncontrolled angina * history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities * Pregnant or lactating women * Women of childbearing potential or male patients of reproductive potential * Any other significant medical or psychiatric condition, currently uncontrolled by treatment, which may interfere with completion of the study

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1, 'type': 'ACTUAL'}}

Updated at

2023-06-27

1 organization

1 product

1 indication

Organization

Lowell Anthony, MD

Product

Telotristat

Indication

Neuroendocrine Tumors