6 completed, 5 withdrawn, 2 terminated, 1 active not recruiting. 7 Phase 2, 3 Phase 1, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 7 | Withdrawn 3, Completed 2, Terminated 2 |
| Phase 1 | 3 | Completed 3 |
| Phase 3 | 2 | Active not recruiting 1, Withdrawn 1 |
Follow telotristat ethyl: new trials by email Literature Review of telotristat ethyl trials Research Report on telotristat ethyl
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Telotristat Ethyl for Reducing Intraoperative Carcinoid Crisis in Patients With Neuroendocrine Tumors Telotristat Ethyl Oral Tablet - Neuroendocrine Tumors | Phase 2 | Withdrawn | University of Chicago | 2022-01-01 | 2021-12-17 | |
| Telotristat With Lutathera in Neuroendocrine Tumors Telotristat (Low-Dose), Telotristat (High-Dose) - Neuroendocrine Tumors | Phase 2 | Terminated | Lowell Anthony, MD | 1 | 2021-09-13 | 2023-06-27 |
| Telotristat Ethyl for the Treatment of Carcinoid Heart Disease in Patients With Metastatic Neuroendocrine Tumor Placebo Administration, Questionnaire Administration, Telotristat Ethyl - Locally Advanced Neuroendocrine Neoplasm, Metastatic Neuroendocrine Neoplasm | Phase 3 | Active not recruiting | M.D. Anderson Cancer Center | 79 | 2021-05-18 | 2026-10-15 |
| 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 Telotristat ethyl, Peptide Receptor Radionuclide Therapy, Placebo - Neuroendocrine Tumors, Carcinoid Syndrome | Phase 2 | Withdrawn | Chandrikha Chandrasekhara | 2021-03-03 | 2023-02-10 | |
| Retifanlimab (INCMGA00012) and Telotristat Ethyl for the Treatment of Advanced Neuroendocrine Tumors and Carcinoid Syndrome Retifanlimab, Telotristat Ethyl - Advanced Neuroendocrine Neoplasm, Carcinoid Syndrome | Phase 2 | Withdrawn | M.D. Anderson Cancer Center | 2021-03-01 | 2021-09-29 | |
| Open Label Study to Analyze the Effect of Telotristat Ethyl on Weight Regulation/Gain telotristat ethyl - Pancreatic Cancer, Neuroendocrine Tumors | Withdrawn | Andrew Hendifar, MD | 2020-10-01 | 2020-12-30 | ||
| Lanreotide Combined With Telotristat Ethyl or Placebo for the First-line Treatment in Patients With Advanced Well Differentiated Small Intestinal Neuroendocrine Tumours (siNET) With Highly-functioning Carcinoid Syndrome Telotristat Ethyl, Lanreotide - Small Intestinal NET, Carcinoid Heart Disease | Phase 3 | Withdrawn | European Organisation for Research and Treatment of Cancer - EORTC | 2020-04-01 | 2020-02-05 | |
| Telotristat Ethyl to Promote Weight Stability in Patients With Advanced Stage Pancreatic Cancer Gemcitabine, Nab-paclitaxel, Telotristat Ethyl - Locally Advanced Unresectable Pancreatic Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma | Phase 2 | Completed | Emory University | 23 | 2019-04-17 | 2025-12-16 |
| A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer telotristat ethyl - Biliary Tract Cancer (BTC) | Phase 2 | Terminated | TerSera Therapeutics LLC | 53 | 2019-03-13 | 2023-04-19 |
| AMT-PET in Monitoring Telotristat Etiprate Treatment in Participants With MetastaticNeuroendocrine Neoplasm Carbon C 11 Alpha-methyltryptophan, Laboratory Biomarker Analysis, Positron Emission Tomography - Carcinoid Syndrome, Metastatic Nonfunctional Well Differentiated Neuroendocrine Neoplasm | Phase 2 | Completed | Barbara Ann Karmanos Cancer Institute | 4 | 2018-06-20 | 2025-04-10 |
| Study to Compare a Dose of Telotristat Etiprate in Subjects With Renal Impairment With Matched Subjects With Normal Renal Function Telotristat etiprate - Renal Impairment | Phase 1 | Completed | Ipsen | 16 | 2018-02-09 | 2020-04-08 |
| Study to Evaluate the Pharmacokinetics of Telotristat Ethyl in Subjects With Severe Hepatic Impairment Telotristat Ethyl - Hepatic Impairment | Phase 1 | Completed | Lexicon Pharmaceuticals | 16 | 2017-11-28 | 2018-10-15 |
| A Phase 1 Study to Evaluate the Effects of Omeprazole and Famotidine on the Absorption of Telotristat Ethyl in Healthy Subjects Omeprazole 40 MG, Famotidine 40 mg, Telotristat ethyl 250 mg - Drug-drug Interaction | Phase 1 | Completed | Lexicon Pharmaceuticals | 32 | 2017-09-21 | 2018-04-25 |
| Real-world Evidence Study EvaLuating PAtient-Reported Outcomes With XERMELO Xermelo - Carcinoid Syndrome | Completed | TerSera Therapeutics LLC | 223 | 2017-06-22 | 2024-07-24 |
Neuroendocrine Tumors (6) · Serotonin Syndrome (5) · Pancreatic Neoplasms (2) · Biliary Tract Neoplasms (1) · Cachexia (1) · Carcinoid Heart Disease (1) · Carcinoid Tumor (1) · Diarrhea (1) · Neoplasms (1) · Renal Insufficiency (1)
Lexicon Pharmaceuticals (2) · M.D. Anderson Cancer Center (2) · TerSera Therapeutics LLC (2) · Andrew Hendifar, MD (1) · Barbara Ann Karmanos Cancer Institute (1) · Chandrikha Chandrasekhara (1) · Emory University (1) · European Organisation for Research and Treatment of Cancer - EORTC (1) · Ipsen (1) · Lowell Anthony, MD (1) · University of Chicago (1)
United States (9) · Belgium (1) · Germany (1) · Moldova (1) · Romania (1)
Suman Wason, MD (2) · Al B Benson, MD (1) · Andrew Hendifar, MD, MPH (1) · Angela Lamarca (1) · Anthony Shields (1) · Cezar A Iliescu, MD (1) · Chandrikha Chandrasekharan, MD (1) · Daniel M Halperin, MD (1) · Gehan Botrus, MD, PhD (1) · Janine North, BS (1) · Juan Valle (1) · Lowell Anthony, MD (1) · Renuka Iyer, M.D. (1) · Richard Kim, M.D. (1)
2017 (1), P30CA022453 (1)