セルメチニブ（AZD6244、ARRY-142886）J-BTC第1相試験

基本情報

NCT ID: NCT01949870
ステータス: 中止
試験のフェーズ: 第1相
試験タイプ: 介入
目標被験者数: 6
治験依頼者名: AstraZeneca

概要

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.

対象疾患

Inoperable Locally Advanced or Metastatic Biliary Tract Cancer

介入

Cisplatin(DRUG)

Gemcitabine(DRUG)

Selumetinib(DRUG)

依頼者（Sponsor）

アストラゼネカ株式会社(INDUSTRY)

実施施設 (2)

AZD6244 PhI Japanese Gem/

Chuo Ku, Tokyo, Japan

AZD6244 PhI Japanese Gem/

Kashiwa Shi, Chiba, Japan