Ignite Creation Date:
2024-05-06 @ 2:00 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01949870
Status:
TERMINATED
Last Update Posted:
2016-05-13
First Post:
2013-09-10
Brief Title:
Selumetinib AZD6244 ARRY-142886 J-BTC Phase 1 Study
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase I Open-Label Multi-Center Study to Assess the Safety and Tolerability of Selumetinib AZD6244 ARRY-142886 in Combination With CisplatinGemcitabine in Japanese Patients With Inoperable Locally Advanced or Metastatic Biliary Tract Cancer BTC
Status:
TERMINATED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
change in the development strategy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None