Cholangiocarcinoma Clinical Trial
Official title:
ABC-04 a Phase 1B Study of Cisplatin, Gemcitabine and Selumetinib in Patients With Advanced Biliary Tract Cancer
The objective of this study is to establish the recommended dose of selumetinib, a novel MEK inhibitor for use in combination with gemcitabine and cisplatin.
This trial aims to evaluate the safety and tolerability of selumetinib in combination with
CisGem and to establish the recommended dose to take into phase II studies. Pharmacokinetic
and pharmacodynamic endpoints will be assessed and preliminary efficacy data will also be
collected.
Patients with Advanced Biliary tract Cancer will receive CisGem regimen and selumetinib. A
dose de-escalation scheme will be employed to determine the recommended phase II dose of
selumetinib.
Patients will be recruited in cohorts of three and assessed for dose limiting toxicity (DLT)
during the first cycle of treatment. Depending on the number of DLTs observed, the cohort
may be expanded, the next cohort may be enrolled at a lower dose or the dose may be declared
the recommended dose. Patients will receive up to eight cycles of CisGem and may continue to
receive selumetinib until progression of disease.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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