Study identifier:D1532C00075
ClinicalTrials.gov identifier:NCT01949870
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I, Open-Label, Multi-Center Study to Assess the Safety and Tolerability of Selumetinib (AZD6244, ARRY-142886) in Combination with Cisplatin/Gemcitabine in Japanese Patients with Inoperable Locally Advanced or Metastatic Biliary Tract Cancer (BTC)
Inoperable Locally Advanced or Metastatic Biliary Tract Cancer
Phase 1
No
Cisplatin, Gemcitabine, Selumetinib
All
6
Interventional
20 Years - 150 Years
Allocation: N/A
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Apr 2016 by AstraZeneca
AstraZeneca
-
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.
Location
Location
KASHIWA SHI, Chiba, Japan
Location
CHUO KU, Tokyo, Japan
Arms | Assigned Interventions |
---|---|
Other: Selumetinib 25mg/day, 50mg/day and 75mg/day | Drug: Cisplatin day1 and day8 at each cycle Drug: Gemcitabine day1 and day8 at each cycle Drug: Selumetinib 25mg/day, 50mg/day and 75mg/day Other Name: AZD6244 |
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