Cancer Clinical Trial
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
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 0.5 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 0.5 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 .
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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