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Type(s) of Cancer
Colorectal
Study Phase
Phase 3
Study Completion Date
March 2010
NCT00457691Uploaded 01-16-2015
Available for Download
PDS UID: Colorec_Pfizer_2007_114
A Multicenter, Randomised, Double-Blind, Phase 3 Study Of Sunitinib In Metastatic Colorectal Cancer Patients Receiving Irinotecan, 5-Fluorouracil And Leucovorin (FOLFIRI) As First Line Treatment
Provider Information
Provider Data DescriptionThis study was a prospective, multicenter, randomized (1:1), double-blind, placebo-controlled, parallel-arm, Phase 3 clinical trial to evaluate the efficacy and safety of sunitinib versus placebo in metastatic colorectal cancer patients receiving FOLFIRI (irinotecan, 5-FU and leucovorin) in the first-line treatment setting. Only patients for whom FOLFIRI was clinically indicated and have not been previously treated for metastatic disease were eligible to participate.
SponsorPfizer
Data ProviderPfizer
Partial set or SubsetOriginal Data
Patients in dataset768
# of Patients Control382
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/f7vc-zt14
CDISC StandardRaw or Case Report Form data
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe purpose of the study is to evaluate the safety and efficacy of FOLFIRI (Irinotecan, Leucovorin and 5 Fluorouracil) chemotherapy when combined with sunitinib or FOLFIRI chemotherapy without adding sunitinib as the first line treatment of patients with metastatic colorectal cancer.
ConditionsMetastatic Colorectal Cancer
Intervention TypeDrug: 5 fluorouracil
Drug: irinotecan
Drug: levo- leucovorin
Drug: sunitinib
Drug: 5 fluorouracil
Drug: irinotecan
Drug: levo- leucovorin
Drug: placebo
Drug(s)Drug: 5 fluorouracil
Drug: irinotecan
Drug: levo- leucovorin
Drug: sunitinib
Drug: placebo
Total Enrolled768
RandomizationRandomized
Blinding MethodDouble
Arms Intervention1 - Experimental
2 - Placebo Comparator
Secondary IDN/A
PubMed (PMID)23358972
Collaborator(s)N/A
Region(s)Argentina
Australia
Austria
Belgium
Bosnia and Herzegovina
Brazil
Bulgaria
Canada
Chile
Colombia
Cyprus
Czech Republic
Germany
Hong Kong
Hungary
India
Ireland
Korea, Republic of
Mexico
Norway
Poland
Portugal
Romania
Russian Federation
Serbia
Singapore
Slovakia
South Africa
Spain
Sweden
Taiwan
Thailand
Ukraine
United Kingdom
Age Range18 Years and older (Adult, Older Adult)
Files:
PROTOCOLA6181122 Final Protocol 28 AUGUST 2007_1.pdf
CRFA6181122 Case Report Form.pdf
DATA DICTIONARYA6181122_SPECS.xlsx
DATA (COMPARATOR ARM)adverse.sas7bdat
DATA (COMPARATOR ARM)cd_b_p.sas7bdat
DATA (COMPARATOR ARM)cn_6_p.sas7bdat
DATA (COMPARATOR ARM)cn_7_p.sas7bdat
DATA (COMPARATOR ARM)cn_8_p.sas7bdat
DATA (COMPARATOR ARM)condrug.sas7bdat
DATA (COMPARATOR ARM)contrt.sas7bdat
DATA (COMPARATOR ARM)demog.sas7bdat
DATA (COMPARATOR ARM)ecg.sas7bdat
DATA (COMPARATOR ARM)final.sas7bdat
DATA (COMPARATOR ARM)iota_p.sas7bdat
DATA (COMPARATOR ARM)lab_safe.sas7bdat
DATA (COMPARATOR ARM)pfm_p.sas7bdat
DATA (COMPARATOR ARM)phyexam.sas7bdat
DATA (COMPARATOR ARM)prevdis.sas7bdat
DATA (COMPARATOR ARM)primdiag.sas7bdat
DATA (COMPARATOR ARM)random.sas7bdat
DATA (COMPARATOR ARM)testdrug.sas7bdat
DATA (COMPARATOR ARM)tmm_p.sas7bdat
DATA (COMPARATOR ARM)vitals.sas7bdat
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