Conditions: Inoperable Locally Advanced or Metastatic Biliary Tract Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 6
Healthy volunteers: no

Brief summary:
The objective of this study is to investigate the safety and tolerability of oral dose of selumetinib in combination with chemotherapies (cisplatin and gemcitabine) in Japanese patients with advanced biliary tract cancer (BTC). In addition, the pharmacokinetic (PK) profile of selumetinib and chemotherapies will be investigated. Also, the Maximum tolerated dose (MTD) of selumetinib in combination with chemotherapies for Japanese BTC patients will be identified, if possible.

Detailed description:

Arms:
arm 1: 25mg/day, 50mg/day and 75mg/day

Interventions: intervention 1: Cisplatin intervention 2: Gemcitabine intervention 3: Selumetinib
Intervention descriptions: intervention 1: day1 and day8 at each cycle intervention 2: day1 and day8 at each cycle intervention 3: 25mg/day, 50mg/day and 75mg/day

Protocol document: