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Phase II Study of Cetuximab With or Without OSI-906 in Head and Neck Squamous Cell Carcinoma (HNSCC)

NCT01427205 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2013-04-05

No results posted yet for this study

Summary

The goal of this clinical research study is to learn if the addition of OSI-906 to cetuximab can improve response. The safety of these drugs will also be studied.

Objectives:

Primary Objective(s): To assess progression-free survival (PFS) among patients with head and neck squamous cell carcinoma (HNSCC) treated with a combination of cetuximab plus OSI-906 and compare it with PFS among patients treated with cetuximab plus placebo.

Secondary Objective(s):

* To assess the safety and toxicity of these treatment regimens.
* To assess the efficacy of these two treatment regimens in terms of overall survival, response rate, and disease control rate
* To assess the efficacy of single agent OSI-906 following cetuximab treatment in terms of response rate and disease control rate in patients who cross-over from Arm B to receive single-agent OSI-906
* To explore blood-based and tissue biomarkers

Conditions

Interventions

DRUG

Cetuximab

Loading dose 400 mg/m2 by vein once followed by 250 mg/m2 weekly (+/- 7 days).

DRUG

OSI-906

150 mg by mouth twice a day.

OTHER

Placebo

Placebo taken by mouth twice daily.

Sponsors & Collaborators

  • OSI Pharmaceuticals

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • William N. William Jr., MD · UT MD Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-06-30

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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 NCT01427205 on ClinicalTrials.gov