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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
Results First Received: April 27, 2011  
Study Type: 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
Condition: Colorectal Cancer
Interventions: Drug: Vandetanib
Drug: FOLFIRI

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First patient randomised 14 March 2007, last patient randomised 21 Jan 2008, data cut off data 31 March 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Vandetanib 100 mg Plus FOLFIRI vandetanib 100 mg plus FOLFIRI
Vandetanib 300 mg Plus FOLFIRI vandetanib 300 mg plus FOLFIRI
Placebo Plus FOLFIRI placebo plus FOLFIRI

Participant Flow:   Overall Study
    Vandetanib 100 mg Plus FOLFIRI     Vandetanib 300 mg Plus FOLFIRI     Placebo Plus FOLFIRI  
STARTED     35 [1]   36 [1]   35 [1]
COMPLETED     8 [2]   7 [2]   7 [2]
NOT COMPLETED     27     29     28  
Adverse Event                 5                 11                 9  
Condition under investigation worsened                 17                 13                 18  
Withdrawal by Subject                 3                 3                 1  
Other                 2                 2                 0  
[1] randomised patients
[2] ongoing study treatment at data cut-off



  Baseline Characteristics
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Reporting Groups
  Description
Vandetanib 100 mg Plus FOLFIRI vandetanib 100 mg plus FOLFIRI
Vandetanib 300 mg Plus FOLFIRI vandetanib 300 mg plus FOLFIRI
Placebo Plus FOLFIRI placebo plus FOLFIRI
Total Total of all reporting groups

Baseline Measures
    Vandetanib 100 mg Plus FOLFIRI     Vandetanib 300 mg Plus FOLFIRI     Placebo Plus FOLFIRI     Total  
Number of Participants  
[units: participants]
 		  35     36     35     106  
Age  
[units: years]
Mean ( Full Range ) 		  57  
  ( 39 to 80 )   		  57  
  ( 30 to 73 )   		  59  
  ( 37 to 73 )   		  58  
  ( 30 to 80 )  
Gender  
[units: Participants]
 		       
Female     15     13     15     43  
Male     20     23     20     63  



  Outcome Measures

1.  Primary:   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) ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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