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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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00454116
First received: March 28, 2007
Last updated: April 27, 2011
Last verified: April 2011
History of Changes

March 28, 2007
April 27, 2011
March 2007
March 2008   (final data collection date for primary outcome measure)
Number of Patients With an Objective Disease Progression Event [ Time Frame: Tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (28 March 2008 +/-3 days) ] [ Designated as safety issue: No ]
Number of patients with objective disease progression or death (by any cause in the absence of objective progression)
Not Provided
Complete list of historical versions of study NCT00454116 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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
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 Anoxaliplatin and Fluoropyrimidine Containing Regimen

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: Vandetanib
    once daily oral tablet two doses
    Other Names:
    • ZD6474
    • ZACTIMA™
  • Drug: FOLFIRI
    Intravenous infusion
  • Placebo Comparator: 1
    FOLFIRI + placebo vandetanib
    Intervention: Drug: FOLFIRI
  • Experimental: 2
    FOLFIRI + low dose vandetanib
    Interventions:
    • Drug: Vandetanib
    • Drug: FOLFIRI
  • Experimental: 3
    FOLFIRI + high dose vandetanib
    Interventions:
    • Drug: Vandetanib
    • Drug: FOLFIRI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
November 2009
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed colorectal cancer
  • 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 treatment with small molecule tyrosine kinase inhibitors of VEGFR or EGFR eg, erlotinib, gefitinib. Prior monoclonal antibodies are permitted, eg, cetuximab, bevacizumab.
  • Previous adjuvant therapy with irinotecan within 12 months of randomization
  • More than one prior course of chemotherapy for treatment of metastatic colorectal cancer.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Korea, Republic of,   Norway,   Spain,   United Kingdom
 
NCT00454116
D4200C00048
No
MSD
AstraZeneca
Not Provided
Study Director: Zactima Medical Science Director, MD AstraZeneca
AstraZeneca
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP