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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Number of Patients With an Objective Disease Progression Event

Outcome Description:

Number of patients with objective disease progression or death (by any cause in the absence of objective progression)

Outcome 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)

Safety Issue:

No

Principal Investigator

Zactima Medical Science Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D4200C00048

NCT ID:

NCT00454116

Start Date:

March 2007

Completion Date:

November 2009

Related Keywords:

  • Colorectal Cancer
  • Colon Cancer
  • Rectal Cancer
  • Colorectal Neoplasms

Name

Location

Research SiteBattle Kreek, Michigan  
Research SiteAlbany, New York  
Research SiteChattanooga, Tennessee  
Research SiteIvins, Utah