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NCT01577173 · ClinicalTrials.gov registry record · Phase 2

A Study of MEHD7945A Versus Cetuximab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of The Head And Neck

A Phase 2 study of Head and Neck Cancer, sponsored by Genentech.

Completed
Registry status
Phase 2
Development phase
122
Enrollment target
20
Study locations

NCT01577173 is a Phase 2 study of Head and Neck Cancer that has completed, run by Genentech. The registered enrollment target is 122 participants, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (53% lower). The trial reports 20 study locations across 17 states.

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The verdict

NCT01577173, a Phase 2 study of Head and Neck Cancer, has completed, sponsored by Genentech.

COMPLETED
Registry status
Phase 2
Development phase
122 participants
Enrollment target
20
Study locations

Study Summary

This phase II, open-label, randomized study will evaluate the efficacy and safety of MEHD7945A versus cetuximab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck who have progressed during or following platinum-based chemotherapy. Patients will be randomized to receive either MEHD7945A 1100 mg intravenously (iv) every 2 weeks or cetuximab 400 mg/m2 iv loading dose followed by 250 mg/m2 iv weekly. Patients treated with cetuximab (Arm B) may cross-over to MEHD7945A (Arm A) upon central confirmation of progressive disease and upon meeting eligibility criteria. Anticipated time on study treatment is until disease progression or intolerable toxicity occurs.

Conditions Studied

Head and Neck Cancer

Interventions

  • DRUG cetuximab
  • DRUG MEHD7945A

Study Locations (20)

New South Wales

  • - Darlinghurst
  • - Waratah
  • - Wollongong

Massachusetts

  • - Boston
  • - Boston

California

  • - Stanford

Colorado

  • - Aurora

Florida

  • - Miami

Illinois

  • - Chicago

Kentucky

  • - Paducah

Maryland

  • - Baltimore

Trial Details

FieldValue
Enrollment Target 122 participants
Start Date 2012-07
Est. Completion 2015-06
Phase Phase 2

Sponsor

Genentech

332 total trials

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What the Registry Record Tells You About NCT01577173

The ClinicalTrials.gov registry entry for NCT01577173 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 122 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (53% lower). The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Head and Neck Cancer appearing as the primary indexed condition, and to 2 interventions - of which cetuximab is the first listed.

NCT01577173 reports 20 study locations spanning 17 distinct geographic areas - top geographies include New South Wales, Massachusetts, California.

Frequently Asked Questions

What is clinical trial NCT01577173 about?

NCT01577173 is a clinical study titled "A Study of MEHD7945A Versus Cetuximab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of The Head And Neck". This phase II, open-label, randomized study will evaluate the efficacy and safety of MEHD7945A versus cetuximab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck who have progressed during or following platinum-based chemotherapy. Patients will be randomized to recei...

What is the current status of trial NCT01577173?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 122 participants. The study started on 2012-07. Estimated completion is 2015-06.

What conditions does trial NCT01577173 study?

This clinical trial studies the following conditions: Head and Neck Cancer.

What interventions are being tested in trial NCT01577173?

The interventions under investigation include: cetuximab (DRUG), MEHD7945A (DRUG).

Who is sponsoring clinical trial NCT01577173?

This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01577173 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.