Vanderbilt Clinical Trials

Eligibility

Eligible Ages

Over 18 Years

Eligible Genders

All

Accepts Healthy Volunteers

No

Criteria

Subjects must meet all the following criteria for enrollment in the study:

- Histologically proven, Grade 1-2 well differentiated, inoperable, advanced GEP-NETs
(Ki67 ≤20%) Eastern Cooperative Oncology Group (ECOG) status 0-2

- Progressive, SSTR-PET positive (i.e., Krenning score 3 or 4) GEP-NET (GI or
pancreas) following 2-4 cycles of treatment with 177Lu-labeled SSA. Must have
achieved disease control for at least 6 months following Lu-177 SSA. No time limit
is defined between 177Lu-SSA treatment and randomization. There must be at least 1
SSTR-PET imaging-positive measurable site of disease (according to RECIST v1.1) and
no RECIST v1.1 measurable metastatic lesions that are SSTR imaging-negative.

- Adequate renal function, as evidenced by creatinine clearance (CrCl) ≥60 mL/min
(calculated using the Cockcroft-Gault formula) (Cockcroft and Gault, 1976)

- Adequate hematologic function, defined by the following laboratory results:

- Part 2: Hemoglobin concentration ≥5.0 mmol/L (≥8.0 g/dL); ANC ≥1000 cells/µL (≥1000
cells/mm3); platelets ≥75 x 109/L (75 x 103/mm3).

- Total bilirubin ≤3 x upper limit normal (ULN)

- Serum albumin ≥3.0 g/dL unless prothrombin time is within the normal range

Subjects who meet any of the following criteria will be excluded from the study:

- Prior radioembolization

- Significant cardiovascular disease, such as New York Heart Association (NYHA) Class
≥II heart failure, left ventricular ejection fraction (LVEF) <40% or QT interval
corrected for heart rate using Fridericia's formula (QTcF) >450 ms for males and
>470 ms for females.

- Resistant hypertension, defined as uncontrolled blood pressure (BP) >140/90 mmHg
while on optimal doses of at least 3 antihypertensive medications with 1 being a
diuretic (Whelton et al. 2018)

- Uncontrolled diabetes mellitus as defined by hemoglobin A1C (HgB A1C) ≥8% PRRT other
than Lu-177 SSA

- Any condition requiring systemic treatment with high-dose glucocorticoids within 14
days prior to first dose of study treatment and/or which cannot be stopped while on
study. Inhaled or topical steroids are permitted.

- Prior history of liver cirrhosis