Status:
COMPLETED
Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Biliary Tract Cancer
Gallbladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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) a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT00753675
Start Date
October 1 2008
End Date
September 1 2012
Last Update
October 10 2016
Active Locations (15)
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1
Research Site
Brescia, BS, Italy
2
Research Site
Florence, FI, Italy
3
Research Site
Genova, GE, Italy
4
Research Site
Milan, Mi, Italy