MedTrace Logo

Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN )

NCT02633800 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2019-01-07

Study results available
· View outcomes & findings →

Summary

This study will test an investigational study drug called patritumab. It is a 'randomized study' which means participants have an equal chance of being assigned to receive the experimental medication (patritumab) or a substance that looks like the experimental product, but is not (placebo). Patritumab may work when combined with other medications that are approved for the treatment of head and neck cancer. They are called cetuximab, cisplatin or carboplatin. All participants will receive the other medications approved for treatment of head and neck cancer, even if they do not receive the experimental product.

Conditions

  • Head and Neck Neoplasms

Interventions

DRUG

Patritumab

Patritumab initial loading dose is 18 mg/kg IV over 60 minutes followed by a maintenance dose of 9 mg/kg IV over 60 minutes (± 10 minutes) every three weeks

DRUG

Cetuximab

Cetuximab 400 mg/mg/m\^2 IV loading dose, followed by 250 mg/m\^2 weekly

DRUG

Cisplatin

Cisplatin at 100 mg/m\^2 IV infused over 1 hour, every three weeks up to a maximum of 6 cycles

DRUG

Carboplatin

Carboplatin IV over 30 to 60 minutes, every 3 weeks for a maximum of 6 cycles

DRUG

Placebo

Placebo to match patritumab

Sponsors & Collaborators

Principal Investigators

  • Kevin Harrington, Prof, MD · Royal Marsden NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-22
Primary Completion
2018-01-11
Completion
2018-02-21
FDA Drug
Yes

Countries

  • Belgium
  • France
  • Germany
  • Hungary
  • Poland
  • Romania
  • United Kingdom

Study Locations

More Related Trials

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 NCT02633800 on ClinicalTrials.gov