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Patritumab With Cetuximab and a Platinum Containing Therapy for Patients With Head and Neck Cancer

NCT02350712 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-09-11

No results posted yet for this study

Summary

The purpose of this study is to test a study drug called patritumab. Patritumab may work when combined with other medications that are approved in the UK for treating Squamous Cell Carcinoma of the Head and Neck (SCCHN), called cetuximab, cisplatin or carboplatin. It is hoped that patritumab may have some benefit in treating patients with cancer. This study will help identify how much patritumab can be given in combination with cetuximab, and cisplatin or carboplatin. This study will show how safe and how well tolerated patritumab is when these medications are given together.

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Interventions

DRUG

Patritumab

Patritumab initial loading dose is 18 mg/kg IV over 60 minutes, followed in Cycle 2 and beyond with a maintenance dose of 9 mg/kg IV over 60 minutes (+/- 10 minutes) every 3 weeks. Infusion time can be extended to a maximum of 120 minutes for participants unable to tolerate the 60-minute infusion.

DRUG

Cetuximab

Cetuximab initial dose at 400 mg/m2 IV as a 2-hour infusion, followed by 250 mg/m2 IV over 60 minutes weekly.

DRUG

Cisplatin

Cisplatin is given as an IV infusion, over 1 hour, 1 hour after the cetuximab infusion, every 3 weeks up to a maximum of 6 cycles (with standard pre- or post-treatment therapies at the investigator's discretion).

DRUG

Carboplatin

Carboplatin is given as an IV-bolus, over 30-60 minutes, every 3 weeks, for a maximum of 6 cycles (with standard pre- or post-treatment therapies at the investigator's discretion).

Sponsors & Collaborators

Principal Investigators

  • Global Team Leader · Daiichi Sankyo

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-03-31
Completion
2016-06-30

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Companies

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 NCT02350712 on ClinicalTrials.gov