Overview

Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer

Status:
Completed
Trial end date:
2012-09-01
Target enrollment:
0
Participant gender:
All
Summary
The primary objective of the trial is to determine the efficacy of VANDETANIB monotherapy or VANDETANIB plus GEMCITABINE or PLACEBO plus GEMCITABINE in prolonging the progression-free survival (PFS) at the trial closure in patients with advanced (unresectable or metastatic) biliary tract cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Genzyme, a Sanofi Company
Treatments:
Gemcitabine
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