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Type(s) of Cancer
Colorectal
Study Phase
Phase 3
Study Completion Date
2008-10-01
NCT00113763Uploaded 07-13-2019
Available for Download
PDS UID: Colorec_Amgen_2004_310
An Open-label, Randomized, Phase 3 Clinical Trial of ABX-EGF Plus Best Supportive Care Versus Best Supportive Care in Subjects With Metastatic Colorectal Cancer
Provider Information
Provider Data DescriptionThe primary objective of this study was to assess whether panitumumab plus BSC improves progression-free survival compared with BSC alone in this subject population. Secondary objectives were to evaluate survival time, objective response, duration of response, time to response, time to disease progression, time to treatment failure, duration of stable disease, patient-reported outcomes, and the safety profile of panitumumab plus BSC compared with BSC alone in this subject population.
SponsorAmgen
Data ProviderAmgen
Partial set or SubsetOriginal Data
Patients in dataset463
# of Patients Control232
# of Patients Experimental231
DOIN/A
CDISC StandardCRT
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryThe purpose of this study is to determine that panitumumab, using the proposed regimen, will safely increase progression free survival in patients with metastatic colorectal cancer who have failed available treatment options (i.e., patients who developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy).
ConditionsColorectal Cancer
Metastases
Intervention TypeOther: Best supportive care
Drug: Panitumumab
Drug(s)Drug: Panitumumab
Total Enrolled463
RandomizationRandomized
Blinding MethodNone
Arms InterventionPanitumumab plus best supportive care - Experimental
Best Supportive Care - Other
Secondary IDN/A
PubMed (PMID)21448748
21190026
19189371
18040272
17470858
34213592
29627309
26049686
23625191
18316791
Collaborator(s)N/A
Region(s)N/A
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files:
PROTOCOL20020408_Amendment 4_26APR05.pdf
CRFFinal CRF 200704 Ver 2.pdf
DATA DICTIONARYDDT_408_v2.xlsx
DATA (ACTIVE ARM)PDS_DSA_20020408.zip
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