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Colorectal

An Open-label, Randomized, Phase 3 Clinical Trial of Panitumumab Plus Best Supportive Care Versus Best Supportive Care in Subjects with Metastatic Colorectal Cancer

Unique Dataset IDColorec_Amgen_2004_310ClinicalTrial.gov IDNCT00113763
DownloadableYes
SponsorAmgenData ProviderAmgenTotal Study Enrolled Patients463Comparator (Control) Arm Enrolled Patients232Experimental (Active) Arm Enrolled Patients231RandomizationYes
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataBoth comparator and experimental arm dataIntervention TypeTargeted Therapy, Biologics, Best Supportive Care, ChemotherapyDataset TypeOther

Clinical Trial Title

An Open-label, Randomized, Phase 3 Clinical Trial of Panitumumab Plus Best Supportive Care Versus Best Supportive Care in Subjects with Metastatic Colorectal Cancer

Trial Summary and Conditions

The 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).

Data Summary

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

Study Objectives

The 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.

Outcome Measures

Primary Outcome Measure: Progression-free Survival Time. Secondary Outcome Measures: Overall Survival, Objective Tumor Response, Duration of Response, Time to Response, Time to Disease Progression, Time to Treatment Failure, Duration of Stable Disease.

Available Downloads:

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

PROTOCOL: 20020408_Amendment 4_26APR05.pdf

CRF: Final CRF 200704 Ver 2.pdf

DATA DICTIONARY: DDT_408_v2.xlsx

DATA (ACTIVE ARM): PDS_DSA_20020408.zip