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Type(s) of Cancer
Head and Neck
Study Phase
Phase 3
Study Completion Date
2010-05
NCT00460265Uploaded 08-03-2018
Available for Download
PDS UID: HeadNe_Amgen_2007_265
A Phase 3 Randomized Trial of Chemotherapy With or Without Panitumumab in Patients With Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Provider Information
Provider Data DescriptionPrimary Objective - To assess whether panitumumab plus chemotherapy improves overall survival (OS) compared to chemotherapy alone as first line treatment for metastatic and/or recurrent squamous cell carcinoma of the head and neck (SCCHN) Secondary Objectives - To evaluate progression-free survival (PFS), overall response rate (ORR), duration of response (DOR), time to progression (TTP) and safety. Tertiary Objectives - To evaluate time to response (TTR) and patient reported outcomes (PROs) utilizing the validated EUROQOL EQ-5D health state index score and the overall health rating. Exploratory Objectives - To investigate potential biomarker development based on assessment of blood and tumor cells and the proposed mechanism of action of study drugs. In addition, investigate the effect of genetic variation in cancer genes and drug target genes on subject response to study drugs. Primary Endpoint - Efficacy: OS Secondary Endpoints - Efficacy: PFS, ORR, DOR, TTP. Safety: Incidence of adverse events (AEs), significant laboratory changes and human anti-panitumumab antibody (HAPA) formation. Tertiary Endpoints - TTR, Patient reported outcomes using EUROQOL EQ-5D (Health state index score, Overall health rating) Exploratory Endpoints - Investigation of potential biomarker development based on assessment of blood and tumor cells and the proposed mechanism of action of study drug. In addition, investigate the effect of genetic variation in cancer genes and drug target genes on subject response to study drugs. Sample Size - 650 subjects total (325 per treatment arm)
SponsorAmgen
Data ProviderAmgen
Partial set or SubsetOriginal Data
Patients in dataset657
# of Patients Control330
# of Patients Experimental327
DOIhttps://doi.org/10.34949/3eaj-md88
CDISC StandardADS
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryThe purpose of this study is to determine the treatment effect of Panitumumab in combination with chemotherapy versus chemotherapy alone as first line therapy for metastatic and/or recurrent squamous cell carcinoma of the head and neck.
ConditionsRecurrent and/or Metastatic Head and Neck Cancer
Intervention TypeDrug: ARM 2
Drug: ARM 1
Drug(s)Drug: ARM 2
Drug: ARM 1
Total Enrolled658
RandomizationRandomized
Blinding MethodNone
Arms InterventionARM 2 - Active Comparator
ARM 1 - Experimental
Secondary IDN/A
PubMed (PMID)23746666
Collaborator(s)N/A
Region(s)N/A
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files:
PROTOCOL20050251_01.20.01 Protocol Ver 1.0 2006-10-10 English_Redacted.pdf
CRFAmgen 20050251 CRF REDACTED.pdf
DATA DICTIONARYAmgen 20050251 DDT.pdf
DATA (BOTH COMPARATOR AND ACTIVE ARMS)SAS dataset - 20050251.zip
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