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CetuGEX™ in Comparison to Cetuximab for the Treatment of Patients With Head and Neck Cancer

NCT02052960 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2021-11-02

Study results available
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Summary

The aim of the study is to evaluate the efficacy of CetuGEX™ for the treatment of patients with stage III/IV recurrent and/or metastatic SCCHN as compared to cetuximab (both in combination with platinum-based chemotherapy) in terms of progression-free survival (PFS).

Conditions

  • Carcinoma, Squamous Cell of Head and Neck

Interventions

DRUG

CetuGEX™

60 mg/day 0, 930 mg/day 1, followed by 720 mg i.v. weekly administration

DRUG

Cetuximab

400 mg/sqm body surface area (BSA) on day 1, followed by 250 mg/sqm BSA i.v. weekly administration

DRUG

Chemotherapy

Combination of Cisplatin and 5-Fluorouracil (Carboplatin may substitute Cisplatin following the 1st cycle of therapy in case of toxicity)

Sponsors & Collaborators

  • Glycotope GmbH

    lead INDUSTRY

Principal Investigators

  • Ulrich Keilholz, Prof · Charite University, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2017-08-28
Completion
2017-10-04
FDA Drug
Yes

Countries

  • Belgium
  • France
  • Germany
  • Italy
  • Poland
  • Romania
  • Spain

Study Locations

More Related Trials

Entities

Drugs

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 NCT02052960 on ClinicalTrials.gov