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Type(s) of Cancer
Colorectal
Study Phase
Phase 3
Study Completion Date
2009-08-01
NCT00364013Uploaded 08-03-2018
Available for Download
PDS UID: Colorec_Amgen_2006_264
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 DescriptionPrimary Objective - To assess whether panitumumab in combination with infusional 5-fluorouracil, leucovorin and oxaliplatin (FOLFOX) chemotherapy improves progression-free survival (PFS) compared to FOLFOX alone as first-line therapy for metastatic colorectal cancer (mCRC) among subjects with wild-type KRAS tumors and subjects with mutant KRAS tumors. Secondary Objectives - To evaluate overall survival (OS), objective response rate (ORR), duration of response (DOR), time to progression (TTP) and safety and tolerability among subjects with wild-type KRAS tumors and subjects with mutant KRAS tumors. Tertiary Objectives - To evaluate time to response and patient reported outcomes (PRO) among subjects with wild-type KRAS tumors and subjects with mutant KRAS tumors Exploratory Objectives - to investigate potential biomarker development based on assessment of blood cells, tumor cells and the proposed mechanism of action of study drug among subjects with wild-type KRAS tumors and subjects with mutant KRAS tumors. Primary Endpoint - Progression-free survival (PFS) Secondary Endpoints - Efficacy: Overall Survival (OS), Objective Response Rate (ORR), Time to progression (TTP), Duration of response (DOR). Safety: Incidence of AEs and significant laboratory changes Tertiary Endpoints - Time to response, Patient-reported outcomes (EuroQol [EQ-5D]) Exploratory Endpoints - Investigation of potential biomarker development based on assessment of blood cells, tumor cells and the proposed mechanism of action of the study drug. Sample Size - Approximately 1150 subjects (approximately 575 per treatment arm)
SponsorAmgen
Data ProviderAmgen
Partial set or SubsetOriginal Data
Patients in dataset1183
# of Patients Control590
# of Patients Experimental593
DOIhttps://doi.org/10.34949/x1zp-2985
CDISC StandardADS
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
Arms InterventionFOLFOX + Panitumumab - Experimental
FOLFOX - Active Comparator
Secondary IDN/A
PubMed (PMID)24024839
24718886
20921465
25956209
31515083
31378656
30679026
30614531
30019318
29627309
28449055
27843597
26049686
22070868
Collaborator(s)N/A
Region(s)N/A
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files:
PROTOCOL20050203_01.20.01 Protocol Amend 2 2009-01-21 English_Redacted.pdf
CRFAmgen 20050203 CRF REDACTED.pdf
DATA DICTIONARYAmgen 20050203 DDT.pdf
DATA (BOTH COMPARATOR AND ACTIVE ARMS)SAS dataset - 20050203.zip
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