Ignite Creation Date:
2024-05-06 @ 1:59 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01943864
Status:
COMPLETED
Last Update Posted:
2017-05-31
First Post:
2013-09-12
Brief Title:
A Phase IIa Study of the MEK Inhibitor Trametinib Monotherapy in the Treatment of Biliary Tract Cancers
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase IIa Study of the MEK Inhibitor GSK1120212 Monotherapy in the Treatment of Gemcitabine Refractory Locally Advanced Recurrent or Metastatic Biliary Tract Cancers
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase IIa open-label single-arm multi-center study to evaluate the efficacy and safety of orally administered MEK inhibitor trametinib as the second line in subjects with advanced or metastatic biliary tract cancers BTC in Japanese population The primary endpoint of this study is 12 week non-progressive disease PD rate defined as the percentage of subjects without progression at Week 12 As a sub-study pharmacokinetics PK of four tablets of 05 milligram mg tablet or one tablet of 2 mg tablet to achieve 2 mg daily regimen will be assessed to evaluate the pharmacokinetics of trametinib in Japanese population
Eligible subjects will be randomized to receive trametinib at the recommended Phase II dose of 2 mg every day as one 2 mg tablet or four 05 mg tablets on Day 1 From Day 2 until disease progression or withdrawal from the study treatment all subjects will receive one tablet of 2 mg trametinib Disease assessment will be performed every 8 week Translational research is also planned to evaluate the potential blood or tumor tissue-derived biomarkers for biological activity and sensitivity or resistance to treatment with trametinib
Eligible subjects will be randomized to receive trametinib at the recommended Phase II dose of 2 mg every day as one 2 mg tablet or four 05 mg tablets on Day 1 From Day 2 until disease progression or withdrawal from the study treatment all subjects will receive one tablet of 2 mg trametinib Disease assessment will be performed every 8 week Translational research is also planned to evaluate the potential blood or tumor tissue-derived biomarkers for biological activity and sensitivity or resistance to treatment with trametinib
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None