Ignite Creation Date:
2024-05-06 @ 12:35 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03790111
Status:
TERMINATED
Last Update Posted:
2023-04-19
First Post:
2018-12-25
Brief Title:
A Safety and Efficacy Study of XERMELO First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer
Sponsor:
TerSera Therapeutics LLC
Organization:
TerSera Therapeutics LLC
Study Overview
Official Title:
A Phase 2 Multicenter Open-label Safety and Efficacy Study of XERMELO Telotristat Ethyl Plus First-line Chemotherapy in Patients With Locally Advanced Unresectable Recurrent or Metastatic Biliary Tract Cancer BTC
Status:
TERMINATED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Did not meet pre-specified Progression-Free Survival at Month 6 for Stage 2 Analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TELE-ABC
Brief Summary:
A Phase 2 multicenter open-label 2-stage study to assess the safety tolerability and efficacy of XERMELO in combination with first-line 1L therapy cisplatin cis plus gemcitabine gem
Detailed Description:
A Phase 2 multicenter open-label 2-stage study to assess the safety tolerability and efficacy of XERMELO in combination with first-line 1L therapy cis plus gem in patients with unresectable locally advanced recurrent or metastatic biliary tract cancer intrahepatic or extrahepatic cholangiocarcinoma gallbladder cancer who are naïve to tumor-directed therapy in the locally advanced or metastatic setting and for which treatment with 1L therapy defined as a combination of cis plus gem is planned
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| LX1606207 | OTHER | Lexicon | None |
| LX1606207 | OTHER | None | None |