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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_309ClinicalTrial.gov IDNCT00364013
DownloadableYes
SponsorAmgenData ProviderAmgenTotal Study Enrolled Patients1183Comparator (Control) Arm Enrolled Patients590Experimental (Active) Arm Enrolled Patients593RandomizationYes
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataBoth comparator and experimental arm dataIntervention TypeChemotherapy, Biologics, Targeted TherapyDataset TypeOther

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

This phase 3, multicenter, open-label, randomized clinical trial was conducted 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

The primary objective of this study was to assess whether panitumumab in combination with FOLFOX chemotherapy improves PFS compared to FOLFOX alone as first-line therapy for mCRC among subjects with wild-type KRAS tumors and subjects with mutant KRAS tumors. The secondary objectives were to evaluate OS, objective response rate, duration of response, time to progression, and safety and tolerability among subjects with wild-type KRAS tumors and subjects with mutant KRAS tumors.

Outcome Measures

Primary Outcome: Progression-free Survival. Secondary Outcome: Overall Survival, Percentage of Participants With an Objective Response, Time to Progression, Duration of Response, Number of Participants With Adverse Events.

Available Downloads:

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

PROTOCOL: Protocol Amend 2 2009-01-21 English_2.pdf

CRF: AMG_954_20050203v0_3.pdf

DATA DICTIONARY: DDT_203_v2.xlsx

DATA (BOTH COMPARATOR AND ACTIVE ARMS): PDS_DSA_20050203.zip