CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 240 enrolled
Drug / intervention
CetuGEX™ +2 moredrug
Likely dose
CetuGEX™ 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02052960
NCT02052960Phase 2Completed
CompareCT.gov

Randomized, Controlled, Open Label, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of CetuGEX™ Plus CT in Comparison to Cetuximab Plus CT in Patients With Stage III/IV Recurrent and/or Metastatic SCCHN

Glycotope GmbH·interventional·Posted Feb 3, 2014·Updated Nov 2, 2021

In Brief

A Phase 2 clinical trial evaluating CetuGEX™, Cetuximab, and 1 other intervention for Carcinoma, Squamous Cell of Head and Neck. Completed, enrolled 240 participants across 34 sites in 7 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Squamous Cell of Head and Neck
CountriesBelgium, France, Germany, Italy, Poland, Romania, Spain
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 3, 2014
Enrollment StartFeb 1, 2014
Primary CompletionAug 28, 2017
Study CompletionOct 4, 2017
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 12.4 years ago

Interventions

CetuGEX™drug

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

Cetuximabdrug

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

Chemotherapydrug

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