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NCT00939627 · OUTCOME

Gene Expression Levels

Phase II Randomized Trial of the Combination of Cetuximab and Sorafenib or Single Agent Cetuximab · Source last updated 2026-03-10

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Pre-therapy

What was measured

Formalin-fixed, paraffin-embedded (FFPE) tumors were collected. The FFPE tumors were to be evaluated for p16 expression using immunohistochemistry staining with antibody. Gene Expression Levels (positive when \>70% cells stained, otherwise negative) were to be described using frequencies.

Analysis population: Due to an insufficient amount of tumor tissue available to complete planned analysis, this analysis was abandoned.

Groups in this outcome

Arm A - Cetuximab

Patients were to receive cetuximab 400 mg/m\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.

Arm B - Cetuximab and Sorafenib Tosylate

Patients received cetuximab 400 mg/m\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm A - Cetuximab0
Arm B - Cetuximab and Sorafenib Tosylate0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Formalin-fixed, paraffin-embedded (FFPE) tumors were collected. The FFPE tumors were to be evaluated for p16 expression using immunohistochemistry staining with antibody. Gene Expression Levels (positive when \>70% cells stained, otherwise negative) were to be described using frequencies.
groups
  1. description
    Patients were to receive cetuximab 400 mg/m\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
    id
    OG000
    title
    Arm A - Cetuximab
  2. description
    Patients received cetuximab 400 mg/m\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
    id
    OG001
    title
    Arm B - Cetuximab and Sorafenib Tosylate
population Description
Due to an insufficient amount of tumor tissue available to complete planned analysis, this analysis was abandoned.
reporting Status
POSTED
time Frame
Pre-therapy
title
Gene Expression Levels
type
SECONDARY

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice