A Phase II, Double Blind Study of 2 Doses of ZACTIMA™(ZD6474) in Combination With FOLFIRI vs FOLFIRI Alone for the Treatment of Colorectal Cancer in Patients
NCT ID: NCT00454116
Last Updated: 2016-10-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
106 participants
INTERVENTIONAL
2007-03-31
2009-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase II Study of 2 Doses of ZD6474 (Vandetanib) in Combination With FOLFOX vs FOLFOX Alone for the Treatment of Colorectal Cancer
NCT00500292
Study to Assess the Efficacy and Safety of Treatment With FOLFIRI-aflibercept Compared to Initial Treatment With FOLFIRI-aflibercept (for 6 Cycles) Followed by Maintenance With 5FU-aflibercept, in an Elderly Population With mCRC After Failure of an Oxaliplatin-based Regimen
NCT03279289
Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen
NCT00561470
FOLFOX +/- Ziv-Aflibercept for Esophageal and Gastric Cancer
NCT01747551
Safety, Tolerability and Efficacy of ZD6126 in Combination With Oxaliplatin, 5-Fluorouracil and Leucovorin in Subjects With Metastatic Colorectal Cancer.
NCT00065117
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
FOLFIRI + placebo vandetanib
FOLFIRI
Intravenous infusion
2
FOLFIRI + low dose vandetanib
Vandetanib
once daily oral tablet two doses
FOLFIRI
Intravenous infusion
3
FOLFIRI + high dose vandetanib
Vandetanib
once daily oral tablet two doses
FOLFIRI
Intravenous infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vandetanib
once daily oral tablet two doses
FOLFIRI
Intravenous infusion
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen defined as:
* Progression on or following treatment for metastatic colorectal cancer
* Progression within 12 months of adjuvant chemotherapy for colorectal cancer
Exclusion Criteria
* Previous adjuvant therapy with irinotecan within 12 months of randomization
* More than one prior course of chemotherapy for treatment of metastatic colorectal cancer.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Ann Arbor, Michigan, United States
Research Site
New York, New York, United States
Research Site
Nashville, Tennessee, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Buenos Aires, , Argentina
Research Site
Ramos Mejía, , Argentina
Research Site
Rosario, , Argentina
Research Site
Santa Fe, , Argentina
Research Site
Vicente López, , Argentina
Research Site
Bergen, , Norway
Research Site
Oslo, , Norway
Research Site
Stavanger, , Norway
Research Site
Seoul, , South Korea
Research Site
A Coruña, , Spain
Research Site
Barcelona, , Spain
Research Site
Jaén, , Spain
Research Site
Lleida, , Spain
Research site
Belfast, Northern Ireland, United Kingdom
Research Site
Aberdeen, , United Kingdom
Research Site
Leicester, , United Kingdom
Research Site
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2006-005023-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D4200C00048
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.