Cediranib Versus Placebo Plus Cisplatin/Gemcitabine Chemotherapy for Patients With Advanced Biliary Tract Cancers

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

April 30, 2011

Primary Completion Date

September 30, 2012

Study Completion Date

September 30, 2014

Conditions
Biliary Tract Neoplasms
Interventions
DRUG

gemcitabine

gemcitabine 1000 mg/m2 on days 1 and 8 of a 21-day cycle for 24 weeks in the absence of disease progression

DRUG

cisplatin

cisplatin 25 mg/m2 on days 1 and 8 of a 21-day cycle for 24 weeks in the absence of disease progression

DRUG

Placebo

20mg od (continuous dosing) until evidence of disease progression has been confirmed

DRUG

cisplatin

cisplatin 25 mg/m2 on days 1 and 8 of a 21-day cycle for 24 weeks in the absence of disease progression

DRUG

cediranib

cediranib 20mg oral daily (continuous dosing)until evidence of disease progression has been confirmed

DRUG

gemcitabine

gemcitabine 1000 mg/m2 on days 1 and 8 of a 21-day cycle for 24 weeks in the absence of disease progression

Trial Locations (2)

NW1 2PQ

University College London Hospitals NHS Foundation Trust, London

M20 4BX

The Christie NHS Foundation Trust, Manchester

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

University College, London

OTHER