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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	19 March 2012
Main ID:	EUCTR2004-004021-98-IT
Date of registration:	28/06/2005
Prospective Registration:	No
Primary sponsor:	ROCHE
Public title:	A single arm phase IV study to assess efficacy and safety of bevacizumab in combination with irinotecan and infusional 5-fluorouracil/folinic acid regimens as first line treatment for patients with metastatic colorectal cancer.
Scientific title:	A single arm phase IV study to assess efficacy and safety of bevacizumab in combination with irinotecan and infusional 5-fluorouracil/folinic acid regimens as first line treatment for patients with metastatic colorectal cancer.
Date of first enrolment:	12/05/2005
Target sample size:
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-004021-98
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: no Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
Phase:

Countries of recruitment
Italy	Spain

Contacts

Name:
Address:
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Affiliation:

Name:
Address:
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Key inclusion & exclusion criteria

Inclusion criteria:
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

metastatic colorectal carcinoma
MedDRA version: 6.1 Level: PT Classification code 10052358

Intervention(s)

Product Name: NA
Product Code: NA
Pharmaceutical Form: Solution for infusion
Current Sponsor code: RO4876646-000
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-

Primary Outcome(s)

Primary end point(s):

Secondary Objective:

Main Objective:

Secondary Outcome(s)

Secondary ID(s)

MO 18458

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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