CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 106 enrolled
Drug / intervention
Vandetanib +1 moredrug
Likely dose
Vandetanib two doses once daily oral tablet in combination with FOLFIRI (IV infusion)AI-extracted
Key inclusion· 4
  • ✓Histologically confirmed colorectal cancer
  • ✓Progression on or after treatment for metastatic colorectal cancer
  • ✓Progression within 12 months of adjuvant chemotherapy for colorectal cancer
  • ✓Prior failure with oxaliplatin and fluoropyrimidine-containing regimen
Key exclusion· 3
  • ✕Prior treatment with small molecule tyrosine kinase inhibitors of VEGFR or EGFR (e.g., erlotinib, gefitinib)
  • ✕Prior adjuvant irinotecan within 12 months of randomization
  • ✕More than one prior course of chemotherapy for metastatic colorectal cancer

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00454116
NCT00454116Phase 2Completed
CompareCT.gov

A Phase II, Double Blind, Placebo Controlled, Randomised Study to Assess the Efficacy and Safety of 2 Doses of ZACTIMA™(ZD6474) in Combination With FOLFIRI vs FOLFIRI Alone for the Treatment of Colorectal Cancer in Patients Who Have Failed Therapy With an Oxaliplatin and Fluoropyrimidine Containing Regimen

Genzyme, a Sanofi Company·interventional·Posted Mar 30, 2007·Updated Oct 7, 2016

In Brief

A Phase 2 clinical trial evaluating Vandetanib and FOLFIRI for Colorectal Cancer. Completed, enrolled 106 participants across 21 sites in 6 countries.

Detailed Summary

The purpose of this study is to assess the efficacy and safety of 2 doses of ZACTIMA™ (ZD6474) in combination with FOLFIRI vs FOLFIRI alone for the treatment of colorectal cancer in patients who have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer
CountriesArgentina, Norway, South Korea, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 30, 2007
Enrollment StartMar 1, 2007
Primary CompletionMar 1, 2008
Study CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 19.3 years ago

Interventions

Vandetanibdrug

once daily oral tablet two doses

FOLFIRIdrug

Intravenous infusion