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Colorectal

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

Unique Dataset IDColorec_Amgen_2006_263
DownloadableYes
SponsorAmgenData ProviderAmgenTotal Study Enrolled Patients1186Comparator (Control) Arm Enrolled Patients595Experimental (Active) Arm Enrolled Patients591RandomizationYesClinicalTrial.gov IDNCT00339183ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00339183?term=20050181&rank=1
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataBoth comparator and experimental arm dataIntervention TypeChemotherapy, Targeted Therapy, BiologicsDataset TypeADS

Clinical Trial Title

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

Trial Summary and Conditions

The 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.

Data Summary

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

Study Objectives

Primary 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)

Outcome Measures

Primary Outcome Measures : 1. Progression-free Survival (PFS) [ Time Frame: From randomization until the data cut-off date of 8 Apr 2008. Maximum follow-up time was 17 months. ] 2. Overall Survival [ Time Frame: From randomization until the data cut-off date of 30 Apr 2009. Maximum follow-up time was 33 months ] Secondary Outcome Measures : 1. Percentage of Participants With an Objective Response [ Time Frame: Every 8 weeks until disease progression up to the data cut-off date of 30 Apr 2009. Maximum time on follow-up was 33 months. ] 2. Time to Disease Progression [ Time Frame: From randomization until the data cut-off date of 30 Apr 2009. Maximum follow-up time was 33 months ] 3. Duration of Response [ Time Frame: From randomization until the data cut-off date of 30 Apr 2009. Maximum follow-up time was 33 months ] 4. Number of Participants With Adverse Events (AEs) [ Time Frame: From randomization until the data cut-off date of 30 Apr 2009. Maximum follow-up time was 33 mo].

Available Downloads:

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

PROTOCOL: 20050181_01.20.01 Protocol Amend 2 2008-04-04 English_Redacted.pdf

CRF: Amgen 20050181 CRF REDACTED.pdf

DATA DICTIONARY: Amgen 20050181 DDT.pdf

DATA (BOTH COMPARATOR AND ACTIVE ARMS): SAS dataset - 20050181.zip