Trials / Completed
CompletedNCT00753675
Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 174 (actual)
- Sponsor
- Genzyme, a Sanofi Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ZD6474, Vandetanib | 300 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first |
| DRUG | ZD6474, Vandetanib | 100 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first |
| DRUG | Gemcitabine | administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles or until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first |
| DRUG | Placebo matching ZD6474 | Placebo to match ZD6474 100 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first |
Timeline
- Start date
- 2008-10-01
- Primary completion
- 2012-09-01
- Completion
- 2012-09-01
- First posted
- 2008-09-16
- Last updated
- 2016-10-10
- Results posted
- 2013-11-28
Locations
15 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT00753675. Inclusion in this directory is not an endorsement.