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

NCT01949870 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2016-05-13

Study results available
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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.

Conditions

  • Inoperable Locally Advanced or Metastatic Biliary Tract Cancer

Interventions

DRUG

Cisplatin

day1 and day8 at each cycle

DRUG

Gemcitabine

day1 and day8 at each cycle

DRUG

Selumetinib

25mg/day, 50mg/day and 75mg/day

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • Japan

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01949870 on ClinicalTrials.gov