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A Randomized Phase 2 Pharmacokinetic Trial of Chemotherapy With or Without Panitumumab in Patients With Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck

NCT00756444 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2018-11-15

Study results available
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Summary

Study 20080008 was a PK sub-study to study 20050251\[Japan 20050251A\]. This PK protocol was amended 20-March-2009 and is now a Phase 2 stand alone study. There are no sites participating in the U.S.

This study is designed to estimate the effect of panitumumab on the PK of cisplatin and 5-FU in subjects receiving cisplatin and 5-FU with or without panitumumab.

To maximize any potential effect of panitumumab on the PK of cisplatin and 5-FU, the collection of PK samples of cisplatin and 5-FU will be taken during cycle 2 of the study, the point at which the PK of panitumumab is expected to be at steady-state after a dose of 9 mg/kg given every 3 weeks.

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Interventions

DRUG

Panitumumab

This is a PK study comparing Panitumumab plus Chemotherapy to Chemotherapy alone

DRUG

Cisplatin

This is a PK study comparing Panitumumab plus Chemotherapy to Chemotherapy alone

DRUG

5FU

This is a PK study comparing Panitumumab plus Chemotherapy to Chemotherapy alone

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-21
Primary Completion
2012-03-30
Completion
2012-03-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00756444 on ClinicalTrials.gov