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Type(s) of Cancer
Colorectal
Study Phase
Phase 3
Study Completion Date
2006
NCT00339183Uploaded 08-03-2018
Available for Download
PDS UID: Colorec_Amgen_2006_263
N/A
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 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:
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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