Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer (VANGOGH)
Biliary Tract Cancer, Gallbladder Cancer, Cancer Of The Extrahepatic Bile Duct
About this trial
This is an interventional treatment trial for Biliary Tract Cancer focused on measuring Intrahepatic, Cholangiocarcinoma, Vandetanib, Zactima, Advanced, Biliary, Tract, Gallbladder, Extrahepatic Bile Duct, Intrahepatic Cholangiocarcinoma, Ampullary Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically-confirmed advanced (unresectable or metastatic) biliary tract cancer (gallbladder cancer, cancer of the extrahepatic bile duct, intrahepatic cholangiocarcinoma and ampullary carcinoma)
- Patients must have measurable or evaluable but non-measurable disease
- Chemotherapy-naïve (prior chemotherapy in the adjuvant setting completed more than 3 months before the trial entry is accepted).
- WHO performance status 0 to 2: patients must have a WHO PS ≤ 2
Exclusion Criteria:
- Patients must not have received prior systemic therapy for advanced (unresectable or metastatic) disease; prior chemotherapy in the adjuvant setting within 3 months before the trial entry is accepted
- Inadequate end-organ function or Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance wit
- Significant cardiovascular event (e.g. myocardial infarction, superior vena cava [SVC] syndrome, New York Heart Association [NYHA] classification of heart disease ³2) within 3 months before entry, or presence of cardiac disease that in the opinion of
- History of arrhythmia or QTc with Bazett's correction unmeasurable or ≥ 480 msec on screening ECG
Sites / Locations
- Research Site
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Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
A
B
C
Vandetanib 300 mg as a once daily oral dose, from Day 1
Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).