15 completed, 1 terminated. 8 Phase 1, 5 Phase 2, 3 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 8 | Completed 8 |
| Phase 2 | 5 | Completed 4, Terminated 1 |
| Phase 3 | 3 | Completed 3 |
Follow telotristat: new trials by email Literature Review of telotristat trials Research Report on telotristat
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 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 |
| 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 |
| Study to Evaluate a Dose of Telotristat Etiprate in Male and Female With Mild, Moderate and Severe Hepatic Insufficiency and Matched Healthy Subjects telotristat etiprate - Hepatic Impairment | Phase 1 | Completed | Ipsen | 24 | 2016-02-01 | 2019-01-25 |
| An Open-Label Drug-Drug Interaction Study of Telotristat Etiprate and Fexofenadine in Healthy Subjects Fexofenadine, Telotristat etiprate - Drug Interactions | Phase 1 | Completed | Lexicon Pharmaceuticals | 24 | 2014-07-01 | 2014-09-08 |
| Phase 1, Open-label, Drug-drug Interaction Study With Octreotide Acetate Injection and Telotristat Etiprate in Healthy Subjects Telotristat etiprate, Octreotide acetate - Drug Interactions | Phase 1 | Completed | Lexicon Pharmaceuticals | 24 | 2014-07-01 | 2016-09-07 |
| An Open-Label Food Effect Study of Telotristat Etiprate Telotristat etiprate - Healthy | Phase 1 | Completed | Lexicon Pharmaceuticals | 22 | 2014-06-01 | 2014-09-08 |
| A Thorough QT Study of Telotristat Etiprate Telotristat etiprate, Placebo, Moxifloxacin - QT Interval | Phase 1 | Completed | Lexicon Pharmaceuticals | 48 | 2014-05-01 | 2014-09-08 |
| A Open-Label Drug-Drug Interaction Study of Telotristat Etiprate and Midazolam in Healthy Subjects Telotristat etiprate, Midazolam - Drug Interactions | Phase 1 | Completed | Lexicon Pharmaceuticals | 24 | 2014-05-01 | 2014-09-08 |
| Telotristat Etiprate for Carcinoid Syndrome Therapy Telotristat etiprate, Placebo - Carcinoid Syndrome | Phase 3 | Completed | Lexicon Pharmaceuticals | 76 | 2014-03-11 | 2018-02-26 |
| Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms Telotristat etiprate - Carcinoid Syndrome | Phase 3 | Completed | Lexicon Pharmaceuticals | 124 | 2014-01-14 | 2019-09-17 |
| TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome) Telotristat etiprate, Placebo-matching telotristat etiprate - Carcinoid Syndrome | Phase 3 | Completed | Lexicon Pharmaceuticals | 135 | 2013-01-08 | 2018-02-27 |
| A Study to Evaluate Safety and Efficacy of Telotristat Etiprate (LX1606) in Participants With Acute, Mild to Moderate Ulcerative Colitis Telotristat Etiprate, Placebo - Ulcerative Colitis | Phase 2 | Completed | Lexicon Pharmaceuticals | 59 | 2012-01-30 | 2019-05-23 |
| Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome Telotristat etiprate - Carcinoid Syndrome | Phase 2 | Completed | Lexicon Pharmaceuticals | 15 | 2010-06-15 | 2019-03-15 |
| Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome Not Managed by Stable-Dose Octreotide Therapy Telotristat etiprate, Octreotide LAR Depot, Placebo - Carcinoid Syndrome | Phase 2 | Completed | Lexicon Pharmaceuticals | 23 | 2009-03-01 | 2018-12-26 |
Serotonin Syndrome (6) · Colitis, Ulcerative (1) · Neuroendocrine Tumors (1) · Renal Insufficiency (1)
Lexicon Pharmaceuticals (12) · Ipsen (2) · Barbara Ann Karmanos Cancer Institute (1) · Lowell Anthony, MD (1)
United States (13) · Germany (5) · Belgium (4) · United Kingdom (4) · Australia (3) · Canada (3) · France (3) · Israel (3) · Netherlands (3) · Spain (3) · Sweden (3) · Italy (2) · Moldova (2) · Romania (2) · Lithuania (1)
Suman Wason, MD (6) · Pablo Lapuerta, MD (4) · Anthony Shields (1) · Doug Fleming, MD (1) · Lowell Anthony, MD (1) · Pablo LaPuerta, MD (1)
PMID 32146619, PMID 34598813, PMID 25012985, PMID 25636046, PMID 27041406, PMID 29330194, PMID 29724499, PMID 30477789, PMID 31655936, PMID 32157590, PMID 33940581
2009 (1), 2015 (1), 2017 (1), P30CA022453 (1)