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Type(s) of Cancer
Colorectal
Study Phase
Phase 3
Study Completion Date
2006
NCT00364013Uploaded 07-13-2019
Available for Download
PDS UID: Colorec_Amgen_2006_309
N/A
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 SubsetOriginal Data
Patients in dataset1183
# of Patients Control590
# of Patients Experimental593
DOIhttps://doi.org/10.34949/1m76-9m69
CDISC StandardCRT
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryN/A
ConditionsN/A
Intervention TypeBiologics, Targeted Therapy, Chemotherapy
Drug(s)N/A
Total EnrolledN/A
RandomizationN/A
Blinding MethodN/A
Arms InterventionN/A
Secondary IDN/A
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)N/A
Age RangeN/A
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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