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Head-Neck

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)

Unique Dataset IDHeadNe_Amgen_2007_265
DownloadableYes
SponsorAmgenData ProviderAmgenTotal Study Enrolled Patients657Comparator (Control) Arm Enrolled Patients330Experimental (Active) Arm Enrolled Patients327RandomizationYesClinicalTrial.gov IDNCT00460265ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00460265?term=20050251&rank=2
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataBoth comparator and experimental arm dataIntervention TypeTargeted Therapy, Chemotherapy, BiologicsDataset TypeADS

Clinical Trial Title

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)

Trial Summary and Conditions

The 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.

Data Summary

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

Study Objectives

Primary 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)

Outcome Measures

Primary Outcome Measures : 1. Overall Survival [ Time Frame: Up to 56 months ] Secondary Outcome Measures : 1. Overall Response Rate [ Time Frame: Every 6 weeks until disease progression, up to 56 months ] 2. Duration of Response [ Time Frame: Every 6 weeks until disease progression, up to 56 months ] 3. Time to Progression [ Time Frame: Every 6 weeks until disease progression, up to 56 months ] 4. Time to Response [ Time Frame: Every 6 weeks until disease progression, up to 56 months ] 5. Progression Free Survival [ Time Frame: Every 6 weeks until disease progression or deaths, up to 56 months ]

Available Downloads:

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

PROTOCOL: 20050251_01.20.01 Protocol Ver 1.0 2006-10-10 English_Redacted.pdf

CRF: Amgen 20050251 CRF REDACTED.pdf

DATA DICTIONARY: Amgen 20050251 DDT.pdf

DATA (BOTH COMPARATOR AND ACTIVE ARMS): SAS dataset - 20050251.zip