Selumetinib (AZD6244, ARRY-142886) J-BTC Phase 1 Study

Sponsor
AstraZeneca
Study ID
NCT01949870
Phase
PHASE1
Status
Terminated

Conditions

  • Inoperable Locally Advanced or Metastatic Biliary Tract Cancer

Eligibility Criteria

Sex
ALL
Age
20 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Cisplatin — DRUG
    day1 and day8 at each cycle
  • Gemcitabine — DRUG
    day1 and day8 at each cycle
  • Selumetinib — DRUG
    25mg/day, 50mg/day and 75mg/day

Study Details

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.

Key Dates

Start date
Oct 31, 2013
Status verified
May 2016
Primary completion
Aug 31, 2014
Completion
Aug 31, 2014

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Selumetinib
    25mg/day, 50mg/day and 75mg/day

Primary Outcome Measure

The Number of Dose-limiting Toxicities [ Time Frame: The first cycle with selumetinib until Day 1 of Cycle 2 of combination dosing ]