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Type(s) of Cancer
Colorectal
Study Phase
Phase 3
Study Completion Date
2009-04-01
NCT00339183Uploaded 08-03-2018
Available for Download
PDS UID: Colorec_Amgen_2006_263
A Randomized, Multicenter Phase 3 Study to Compare the Efficacy of Panitumumab in Combination With Chemotherapy to the Efficacy of Chemotherapy Alone in Patients With Previously Treated Metastatic Colorectal Cancer
Provider Information
Provider Data DescriptionPrimary Objective - To evaluate the treatment effect of panitumumab plus FOLFIRI on overall survival (OS) and progression-free survival (PFS) compared to FOLFIRI alone as second line therapy for metastatic colorectal cancer (mCRC) among subjects with wild-type KRAS tumors and mutant KRAS tumors Secondary Objectives - To evaluate overall objective response rate (ORR), time to progression (TTP), duration of response (DOR), and safety (subject incidence of AEs and significant laboratory changes) among subjects with wild-type KRAS tumors and mutant KRAS tumors Tertiary Objectives - To evaluate time to response and patient-reported outcomes (PRO) among subjects with wild-type KRAS tumors and mutant KRAS tumors Exploratory Objectives - To investigate potential biomarker development (other than KRAS) based on assessment of blood cells, tumor cells and the proposed mechanism of action of study drugs among subjects with wild-type KRAS tumors and mutant KRAS tumors Primary Endpoints - Efficacy: Overall survival (OS) and progression-free survival (PFS) Secondary Endpoints - Efficacy: overall 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 (EQ-5D health state index score, EQ-5D overall health rating Exploratory Endpoint: Investigation of potential biomarker (other than KRAS) development based on assessment of blood cells, tumor cells and the proposed mechanism of action of study drugs Sample Size: 1100 subjects (approximately 550 per treatment arm)
SponsorAmgen
Data ProviderAmgen
Partial set or SubsetOriginal Data
Patients in dataset1186
# of Patients Control595
# of Patients Experimental591
DOIhttps://doi.org/10.34949/0ws2-w454
CDISC StandardADS
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryThe purpose of this study is to evaluate the treatment effect of panitumumab plus FOLFIRI compared to FOLFIRI alone as second line therapy for metastatic colorectal cancer.
ConditionsMetastatic Colorectal Cancer
Intervention TypeDrug: Panitumumab
Drug: FOLFIRI
Drug(s)Drug: Panitumumab
Drug: FOLFIRI
Total Enrolled1186
RandomizationRandomized
Blinding MethodNone
Arms InterventionPanitumumab Plus FOLFIRI - Experimental
FOLFIRI Alone - Active Comparator
Secondary IDN/A
PubMed (PMID)24356622
20921462
30013091
31902066
29627309
26341920
26049686
22070868
Collaborator(s)N/A
Region(s)N/A
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files:
PROTOCOL20050181_01.20.01 Protocol Amend 2 2008-04-04 English_Redacted.pdf
CRFAmgen 20050181 CRF REDACTED.pdf
DATA DICTIONARYAmgen 20050181 DDT.pdf
DATA (BOTH COMPARATOR AND ACTIVE ARMS)SAS dataset - 20050181.zip
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