Spots Global Cancer Trial Database for Selumetinib (AZD6244, ARRY-142886) J-BTC Phase 1 Study
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Trial Identification
Brief Title: Selumetinib (AZD6244, ARRY-142886) J-BTC Phase 1 Study
Official Title: 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)
Study ID: NCT01949870
Study Description
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:
Keywords
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
AZD6244 PhI Japanese Gem/, Kashiwa Shi, Chiba, Japan
AZD6244 PhI Japanese Gem/, Chuo Ku, Tokyo, Japan
Contact Details
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