Biliary Tract Cancer Clinical Trial
— VANGOGHOfficial title:
A Randomized, Multicentre, Phase II, Parallel-Group Trial of Vandetanib Monotherapy or Vandetanib in Combination With Gemcitabine Versus Gemcitabine Plus Vandetanib Matching Placebo in Subjects With Advanced Biliary Tract Cancer (Gallbladder Cancer, Cancer of the Extrahepatic Bile Duct, Intrahepatic Cholangiocarcinoma and Ampullary Carcinoma)
Verified date | September 2013 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 174 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Research Site | Ancona | |
Italy | Research Site | Aviano | PN |
Italy | Research Site | Brescia | BS |
Italy | Research Site | Firenze | FI |
Italy | Research Site | Genova | GE |
Italy | Research Site | Livorno | |
Italy | Research Site | Milano | Mi |
Italy | Research Site | Napoli | |
Italy | Research Site | Palermo | PA |
Italy | Research Site | Parma | PR |
Italy | Research Site | Pisa | |
Italy | Research Site | Ravenna | |
Italy | Research Site | Reggio Emilia | RE |
Italy | Research Site | Rho | |
Italy | Research Site | Torino |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Italy,
Wedge SR, Ogilvie DJ, Dukes M, Kendrew J, Chester R, Jackson JA, Boffey SJ, Valentine PJ, Curwen JO, Musgrove HL, Graham GA, Hughes GD, Thomas AP, Stokes ES, Curry B, Richmond GH, Wadsworth PF, Bigley AL, Hennequin LF. ZD6474 inhibits vascular endothelial growth factor signaling, angiogenesis, and tumor growth following oral administration. Cancer Res. 2002 Aug 15;62(16):4645-55. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression Free Survival | PFS is calculated from the date of first dose of study medication until the date of objective progression or death (by any cause in the absence of progression). Patients who have not progressed or died at the time of statistical analysis will be censored at the time of their latest objective tumor assessment | up to 1032 days | No |
Secondary | Objective Tumor Response Rate (CR+PR), | ORR is the sum of patients with best overall complete or partial responses divided by the patients in the analysis | up to 1032 days | No |
Secondary | Disease Control Rate (CR+PR+SD) | DCR is the sum of patients with a best overall CR, PR or SD (>=8 weeks) by the patient in the analysis | up to 1032 days | No |
Secondary | Duration of Response (DOR) | DOR is defined from the date of first documentation of response until date of PD or death | up to 1032 days | No |
Secondary | Overall Survivall | OS is defined from the date of randomization to death | up to 1032 days | No |
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