CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 31 enrolled
Drug / intervention
Sorafenib +1 moredrug
Likely dose
Sorafenib 200 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/NCT00815295
NCT00815295Phase 2Completed
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Sorafenib and Cetuximab in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN):a Phase I B/II Trial

Duke University·interventional·Posted Dec 30, 2008·Updated Dec 8, 2014

In Brief

A Phase 2 clinical trial evaluating Sorafenib and Cetuximab for Squamous Cell Cancer. Completed, enrolled 31 participants across 1 site.

Detailed Summary

In this Phase I B/II trial, we seek to determine the safety and efficacy of sorafenib with standard dose cetuximab in the treatment of patients with Recurrent and /or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSquamous Cell Cancer
CountriesUnited States
CollaboratorsBayer

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 30, 2008
Enrollment StartJan 1, 2008
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 17.5 years ago

Interventions

Sorafenibdrug

Phase 1 - Dose level 1 : Sorafenib will be given 200 mg twice daily oral, Phase 1 - Dose level 2 : Sorafenib will be given 400 mg twice daily oral, Phase 2 : Sorafenib will be given at the maximum tolerated dose from Phase 1

Cetuximabdrug

Cetuximab will be given at standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly.