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Colorectal

A Randomized, Multicenter, Phase 3 Study to Compare the Efficacy of Panitumumab in Combination With Oxaliplatin/ 5-fluorouracil/ Leucovorin to the Efficacy of Oxaliplatin/ 5-fluorouracil/ Leucovorin Alone in Patients With Previously Untreated Metastatic Colorectal Cancer

Unique Dataset IDColorec_Amgen_2006_264
DownloadableYes
SponsorAmgenData ProviderAmgenTotal Study Enrolled Patients1183Comparator (Control) Arm Enrolled Patients590Experimental (Active) Arm Enrolled Patients593RandomizationYesClinicalTrial.gov IDNCT00364013ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00364013?term=20050203&rank=1
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataBoth comparator and experimental arm dataIntervention TypeChemotherapy, Biologics, Targeted TherapyDataset TypeADS

Clinical Trial Title

A Randomized, Multicenter, Phase 3 Study to Compare the Efficacy of Panitumumab in Combination With Oxaliplatin/ 5-fluorouracil/ Leucovorin to the Efficacy of Oxaliplatin/ 5-fluorouracil/ Leucovorin Alone in Patients With Previously Untreated Metastatic Colorectal Cancer

Trial Summary and Conditions

The purpose of this study is to determine the treatment effect of panitumumab in combination with FOLFOX compared to FOLFOX alone as first line therapy for metastatic colorectal cancer

Data Summary

Control arm and experimental arm data including demographics, disease characteristics, safety and efficacy

Study Objectives

Primary 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)

Outcome Measures

Primary Outcome Measures : 1. Progression-free Survival [ Time Frame: From randomization until the data cutoff date of 30 Sep 2008. Max. follow-up time was 109 weeks. ] Secondary Outcome Measures : 1. Overall Survival [ Time Frame: From randomization until the data cutoff date of 28 Aug 2009. Max. time on follow-up was 153 weeks. ] 2. Percentage of Participants With an Objective Response [ Time Frame: Every 8 weeks until disease progression up to the data cut-off date of 30 Sep 2008; Max. follow-up time was 109 weeks. ] 3. Time to Progression [ Time Frame: From randomization until the data cut-off date of 30 Sep 2008; Max. follow-up time was 109 weeks. ] 4. Duration of Response [ Time Frame: Every 8 weeks until disease progression up to the data cut-off date of 30 Sep 2008; Max. follow-up time was 109 weeks. ] 5. Number of Participants With Adverse Events (AEs) [ Time Frame: From randomization until the data cut-off date of 28 Aug 2009; Max. time on follow-up was 153 weeks.]

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: 20050203_01.20.01 Protocol Amend 2 2009-01-21 English_Redacted.pdf

CRF: Amgen 20050203 CRF REDACTED.pdf

DATA DICTIONARY: Amgen 20050203 DDT.pdf

DATA (BOTH COMPARATOR AND ACTIVE ARMS): lab.sas7bdat

DATA (BOTH COMPARATOR AND ACTIVE ARMS): SAS dataset - 20050203.zip