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Type(s) of Cancer
Colorectal
Study Phase
Phase 3
Study Completion Date
2006
NCT00364013Uploaded 08-03-2018
Available for Download
PDS UID: Colorec_Amgen_2006_264
N/A
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 SummaryN/A
ConditionsN/A
Intervention TypeChemotherapy, Biologics, Targeted Therapy
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:
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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