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Type(s) of Cancer
Colorectal
Study Phase
Phase 3
Study Completion Date
August 2009
NCT00364013Uploaded 07-13-2019
Available for Download
PDS UID - Colorec_Amgen_2006_309
A Randomized, Multicenter, Phase 3 Study to Compare the Efficacy of Panitumumab in Combination With Oxaliplatin/ 5-fluorouracil/ Leucovorin to the Efficacy of Oxaliplatin/ 5-fluorouracil/ Leucovorin Alone in Patients With Previously Untreated Metastatic Colorectal Cancer
Provider Information
Provider Data DescriptionThe primary objective of this study was to assess whether panitumumab in combination with FOLFOX chemotherapy improves PFS compared to FOLFOX alone as first-line therapy for mCRC among subjects with wild-type KRAS tumors and subjects with mutant KRAS tumors. The secondary objectives were to evaluate OS, objective response rate, duration of response, time to progression, and safety and tolerability among subjects with wild-type KRAS tumors and subjects with mutant KRAS tumors.
SponsorAmgen
Data ProviderAmgen
Partial set or SubsetN/A
Patients in dataset1183
# of Patients Control590
# of Patients Experimental590
DOIN/A
CDISC StandardCRT
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryThe purpose of this study is to determine the treatment effect of panitumumab in combination with FOLFOX compared to FOLFOX alone as first line therapy for metastatic colorectal cancer
ConditionsMetastatic Colorectal Cancer
Intervention TypeDrug: Panitumumab
Drug: FOLFOX regimen
Drug(s)Drug: Panitumumab
Drug: FOLFOX regimen
Total Enrolled1183
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionFOLFOX + Panitumumab - Experimental
FOLFOX - Active Comparator
Secondary IDNA
PubMed (PMID)24024839
24718886
20921465
25956209
31515083
31378656
30679026
30614531
30019318
29627309
27843597
26049686
22070868
Collaborator(s)NA
Region(s)NA
Age RangeMinimum Age: 18 Years
Maximum Age: NA
Files:
PROTOCOLProtocol Amend 2 2009-01-21 English_2.pdf
CRFAMG_954_20050203v0_3.pdf
DATA DICTIONARYDDT_203_v2.xlsx
DATA (BOTH COMPARATOR AND ACTIVE ARMS)PDS_DSA_20050203.zip
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