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Type(s) of Cancer
Colorectal
Study Phase
Phase 3
Study Completion Date
2005
NCT00115765Uploaded 08-03-2018
Available for Download
PDS UID: Colorec_Amgen_2005_262
N/A
Provider Information
Provider Data DescriptionPrimary Objective - To assess whether treatment with panitumumab given concomitantly with every 2 (Q2) week oxaliplatin-based chemotherapy and bevacizumab improves progression- free survival (PFS) compared to treatment with Q2-week oxaliplatin-based chemotherapy and bevacizumab alone. Secondary Objectives - To assess 1) Whether treatment with panitumumab given concomitantly with oxaliplatin-based chemotherapy and bevacizumab improves the following endpoints compared to treatment with oxaliplatin-based chemotherapy and bevicizumab alone: Overall Survival; Response rates (complete [CR] and partial [PR] responses [at week 12 and best overall response during 1st line treatment]); Time to progression (TTP); Time to treatment failure (TTF); Duration of response and Rate of stable disease (SD) and duration of SD. 2) The safety of panitumumab given concomitantly with oxaliplatin-based chemotherapy and bevicizumab as compared to treatment of oxaliplatin-based chemotherapy and bevicizumab alone and 3) The safety and efficacy of panitumumab given concomitantly with irinotecan-based chemotherapy and bevicizumab as compared to treatment of irinotecan-based chemotherapy and bevicizumab alone.
SponsorAmgen
Data ProviderAmgen
Partial set or SubsetOriginal Data
Patients in dataset1053
# of Patients Control525
# of Patients Experimental528
DOIhttps://doi.org/10.34949/a40v-5664
CDISC StandardADS
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryN/A
ConditionsN/A
Intervention TypeBiologics, Chemotherapy, 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:
PROTOCOL20040249_01.20.01 Protocol Amend 2 2007-08-07 English_Redacted.pdf
CRFAmgen 20040249 CRF REDACTED.pdf
DATA DICTIONARYAmgen 20040249 DDT.pdf
DATA (BOTH COMPARATOR AND ACTIVE ARMS)SAS dataset - 20040249.zip
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