A Phase II Study of 2 Doses of ZD6474 (Vandetanib) in Combination With FOLFOX vs FOLFOX Alone for the Treatment of Colorectal Cancer
Primary Purpose
Colorectal, Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Vandetanib
FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal focused on measuring colorectal, cancer, zactima
Eligibility Criteria
Inclusion Criteria:
- Progression on or following treatment for metastatic colorectal cancer
- Have failed therapy with an irinotecan and fluoropyrimidine containing regimen
- Have World Health Organisation (WHO) performance status 0-2 and life expectancy >12 weeks
Exclusion Criteria:
- Previous treatment with small molecule tyrosine kinase inhibitors of VEGFR or EGFR Prior monoclonal antibodies are permitted, (eg, cetuximab, bevacizumab)
- Previous adjuvant therapy with irinotecan within 12 months of randomisation
- More than one prior course of chemotherapy for treatment of metastatic colorectal cancer
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
1
2
3
Arm Description
FOLFOX + Placebo vandetanib
FOLFOX + low dose vandetanib
FOLFOX + high dose vandetanib
Outcomes
Primary Outcome Measures
Number of Patients With an Objective Disease Progression Event
Number of patients with objective disease progression or death (by any cause in the absence of objective progression)
Secondary Outcome Measures
Full Information
NCT ID
NCT00500292
First Posted
July 3, 2007
Last Updated
January 24, 2018
Sponsor
Genzyme, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT00500292
Brief Title
A Phase II Study of 2 Doses of ZD6474 (Vandetanib) in Combination With FOLFOX vs FOLFOX Alone for the Treatment of Colorectal Cancer
Official Title
A Phase II, Double-blind, Placebo Controlled, Randomized Study to Assess the Efficacy and Safety of 2 Doses of ZD6474 (Vandetanib) in Combination With FOLFOX vs FOLFOX Alone for the Treatment of Colorectal Cancer in Patients Who Have Failed Therapy With an Irinotecan and Fluoropyrimidine Regimen
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether treatment with ZACTIMA (vandetanib) in combination with FOLFOX is more effective than FOLFOX alone for colorectal cancer in patients who have failed therapy with an irinotecan and fluoropyrimidine containing regimen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal, Cancer
Keywords
colorectal, cancer, zactima
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
FOLFOX + Placebo vandetanib
Arm Title
2
Arm Type
Experimental
Arm Description
FOLFOX + low dose vandetanib
Arm Title
3
Arm Type
Experimental
Arm Description
FOLFOX + high dose vandetanib
Intervention Type
Drug
Intervention Name(s)
Vandetanib
Other Intervention Name(s)
AZ6474, ZACTIMA™, SAR390530
Intervention Description
once daily oral tablet two dose strengths
Intervention Type
Drug
Intervention Name(s)
FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid
Intervention Description
intravenous infusion
Primary Outcome Measure Information:
Title
Number of Patients With an Objective Disease Progression Event
Description
Number of patients with objective disease progression or death (by any cause in the absence of objective progression)
Time Frame
RECIST 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 (5 March 2008 +/-3 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Progression on or following treatment for metastatic colorectal cancer
Have failed therapy with an irinotecan and fluoropyrimidine containing regimen
Have World Health Organisation (WHO) performance status 0-2 and life expectancy >12 weeks
Exclusion Criteria:
Previous treatment with small molecule tyrosine kinase inhibitors of VEGFR or EGFR Prior monoclonal antibodies are permitted, (eg, cetuximab, bevacizumab)
Previous adjuvant therapy with irinotecan within 12 months of randomisation
More than one prior course of chemotherapy for treatment of metastatic colorectal cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Lille Cedex
Country
France
Facility Name
Research Site
City
Toulouse Cedex 9
Country
France
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Debrecen
Country
Hungary
Facility Name
Research Site
City
Szeged
Country
Hungary
Facility Name
Research Site
City
Seoul
Country
Korea, Republic of
Facility Name
Research Site
City
Bratislava
Country
Slovakia
Facility Name
Research Site
City
Poprad
Country
Slovakia
Facility Name
Research Site
City
Trnava
Country
Slovakia
Facility Name
Research Site
City
Zilina
Country
Slovakia
Facility Name
Research Site
City
Hospitalet deLlobregat
Country
Spain
Facility Name
Research Site
City
Oviedo
Country
Spain
Facility Name
Research Site
City
Santander
Country
Spain
Facility Name
Research Site
City
Taipei
Country
Taiwan
Facility Name
Research Site
City
Tao-Yuan
Country
Taiwan
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=344&filename=CSR-D4200C00047.pdf
Description
Related Info
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=344&filename=CSR-D4200C00047.pdf
Description
CSR-D4200C00047.pdf
Learn more about this trial
A Phase II Study of 2 Doses of ZD6474 (Vandetanib) in Combination With FOLFOX vs FOLFOX Alone for the Treatment of Colorectal Cancer
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