AMT-PET in Monitoring Telotristat Etiprate Treatment in Participants With Metastatic Well Differentiated Neuroendocrine Neoplasm

PRIMARY OBJECTIVES:

I. To evaluate the effect of telotristat etiprate (telotristat ethyl) treatment in patients
with advanced neuroendocrine tumors (NETs) using carbon C 11 alpha-methyltryptophan
(alpha-[11C]methyl-?L-?tryptophan) (AMT)-?positron emission tomography (PET) as measured by
changes in tumor maximum standardized uptake value (SUVmax).

SECONDARY OBJECTIVES:

I. Show that NETs will have increased AMT uptake on PET, as compared to surrounding non-tumor
tissue at baseline.

II. Use compartmental modeling (in tumors with the left ventricle of the heart in the
field-of-view) to measure change in AMT retention.

III. Measure change in AMT retention as mean standardized uptake value (SUVmean).

OUTLINE:

Participants undergo AMT-PET within 7 days prior to, and 9-14 days after start of telotristat
etiprate treatment. Participants receive telotristat etiprate orally (PO) three times a day
(TID) for 9-14 days.

After completion of study treatment, participants are followed up for 3 months.

Inclusion Criteria:

- Histopathologically confirmed, well-?differentiated metastatic NETs

- Documented history of carcinoid syndrome

- Receiving stable-?dose somatostatin analog (long-?acting release [LAR], depot) for > 3
months before enrollment

- Patients with 5-?hydroxyindoleacetic acid (HIAA) levels above or below the upper limit
of normal range (normal: 0 to 15 mg/24 hours) and those with unknown values at
baseline are allowed to participate

- Able to lie within the PET scanner for at least 70 minutes while undergoing scanning

- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or better

- Creatinine =< 2.5 (within 14 days of PET imaging)

- Total bilirubin =< 1.5 x upper limit of normal (ULN) (within 14 days of PET imaging)

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 ULN (within
14 days of PET imaging)

- Patient must have a least one lesion greater than 2 cm on standard imaging (CT, MR,
octreotide, or dotatate imaging) that is judged amenable to AMT-PET

- Women of child bearing potential must not be pregnant or breastfeeding; a negative
urine or blood pregnancy test must be obtained in women with child bearing potential
on the day the prior to the first PET scan; men and women with reproductive potential
must agree to use adequate contraception (hormonal or barrier method of birth control;
abstinence) on study entry and for the duration of study participation

- Eligible and consent signed for imaging with AMT PET under protocol 2011-?053

Exclusion Criteria:

- Patients experiencing more than 12 watery bowel movements per day associated with
volume contraction, dehydration, or hypotension, or showing evidence of enteric
infection are excluded

- Patients are excluded if they had undergone tumor-?directed therapy within 3 months

- Patients cannot be on a targeted agent (e.g., sunitinib or everolimus) or receiving
cytotoxic chemotherapy (e.g., capecitabine or temozolomide); they can?t be on
telotristat ethyl; previous use is acceptable if the patient has been off for over one
month