Status:
COMPLETED
AMT-PET in Monitoring Telotristat Etiprate Treatment in Participants With MetastaticNeuroendocrine Neoplasm
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Carcinoid Syndrome
Metastatic Nonfunctional Well Differentiated Neuroendocrine Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This pilot trial studies how well telotristat etiprate works in treating participants with well differentiated neuroendocrine neoplasm that has spread to other places in the body and monitored by carb...
Detailed Description
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 (al...
Eligibility Criteria
Inclusion
- Histopathologically confirmed, well-differentiated metastatic NETs
- Receiving stable-dose somatostatin analog (long-acting release \[LAR\], depot) for \> 3 months before enrollment.
- Patients with 5-HIAA levels above or below the upper limit of normal range 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.
- ECOG performance status of 2 or better.
- Physical exam, CBC and Multiphasic (including electrolytes, BUN, creatinine, total bilirubin, AST, and ALT) must be done within 28 days of PET imaging and demonstrate adequate renal and liver function. Creatinine ≤ 2.5, total bilirubin ≤ 1.5 x upper limit of normal (ULN). AST and ALT ≤ 2.5 ULN.
- Patient must have a least one lesion greater than 2 cm on standard imaging (CT, MR, octreotide, or dotatate imaging within 8 weeks of the start of the study) 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. 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
- 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 cannnot be on telotristat ethyl; previous use is acceptable if the patient has been off for over one month
Key Trial Info
Start Date :
June 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2020
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03453489
Start Date
June 20 2018
End Date
October 15 2020
Last Update
April 10 2025
Active Locations (1)
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1
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201