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

Study identifier:D1532C00075

ClinicalTrials.gov identifier:NCT01949870

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

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)

Medical condition

Inoperable Locally Advanced or Metastatic Biliary Tract Cancer

Phase

Phase 1

Healthy volunteers

No

Study drug

Cisplatin, Gemcitabine, Selumetinib

Sex

All

Actual Enrollment

6

Study type

Interventional

Age

20 Years - 150 Years

Date

Study Start Date: 01 Oct 2013
Primary Completion Date: 01 Aug 2014
Study Completion Date: 01 Aug 2014

Study design

Allocation: N/A
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria