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A phase 2 trial of Telotristat ethyl in Biliary tract cancer and Biliary tract cancer, run by TerSera Therapeutics LLC, recorded as terminated on the registry.
A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer is a phase 2 interventional study registered as NCT03790111 by TerSera Therapeutics LLC, with 53 participants recorded, started 2019-03-13 and due to reach its primary completion in 2022-01-13. Interventions recorded: telotristat ethyl. Conditions recorded: Biliary Tract Cancer (BTC).
Linked to the drug Telotristat ethyl because the registry names it among its interventions and Biliary tract cancer and Biliary tract cancer among its conditions. Registry record only: no result has been read by an editor.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
53 enrolled.
95% CI 0.74 to 0.93; Figures from the ClinicalTrials.gov results section (first posted 2023-04-19), not from a publication
Source95% CI 4.067 to 7.467; Figures from the ClinicalTrials.gov results section (first posted 2023-04-19), not from a publication
SourceFigures from the ClinicalTrials.gov results section (first posted 2023-04-19), not from a publication
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Project Overall Survival Rate at Month 6primary | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 53 | 0.87 proportion of participants | - | - | link |
| Median Progression Free Survival | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 53 | 6.233 months | - | - | link |
| Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 53 | 7 participants | - | - | link |
Shares Telotristat ethyl and the tag pipeline.
Shares Biliary tract cancer (cholangiocarcinoma) and the tag pipeline.
Shares Biliary tract cancer (cholangiocarcinoma) and the tag pipeline.
Shares Biliary tract cancer (cholangiocarcinoma) and the tag pipeline.
Shares Biliary tract cancer (cholangiocarcinoma) and the tag pipeline.
Shares Biliary tract cancer (cholangiocarcinoma) and the tag pipeline.
Shares Biliary tract cancer (cholangiocarcinoma) and the tag pipeline.
Shares Biliary tract cancer (cholangiocarcinoma) and the tag pipeline.