NCT04713202

Prospective Assessment of Patients With Neuroendocrine Tumors and Current or Prior History of Carcinoid Syndrome or Diarrhea Undergoing Peptide Receptor Radionuclide Therapy With or Without Telotristat Ethyl

Prospective Assessment of Patients With Neuroendocrine Tumors and Current or Prior History of Carcinoid Syndrome or Diarrhea Undergoing Peptide Receptor Radionuclide Therapy With or Without Telotristat Ethyl (NET-PACS Trial) Big Ten Cancer Research Consortium BTCRC-GI19-400

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Chandrikha Chandrasekhara · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The NET-PACS trial is a Prospective Assessment of patients with neuroendocrine tumors and current or prior history of Carcinoid Syndrome or diarrhea undergoing peptide receptor radionuclide therapy with or without telotristat ethyl. The main goal of the study is to demonstrate the feasibility of serial in-depth assessment of patients with neuroendocrine tumors and current or prior history of carcinoid syndrome or diarrhea undergoing treatment with PRRT using telotristat ethyl compared to placebo. We aim to report and describe from a patient's perspective the multi-faceted impact of carcinoid syndrome in patients with NETs and the changes on treatment while getting PRRT using telotristat ethyl compared to placebo.

Conditions

• Neuroendocrine Tumors
• Carcinoid Syndrome
• Diarrhea

Interventions

Type	Name	Description
DRUG	Telotristat ethyl	Telotristat Ethyl, 250mg
DRUG	Peptide Receptor Radionuclide Therapy	Peptide Receptor Radionuclide Therapy
OTHER	Placebo	Placebo

Timeline

• Start date: 2021-03-03
• Primary completion: 2023-02-01
• Completion: 2024-02-01
• First posted: 2021-01-19
• Last updated: 2023-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study