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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: Completed Phase 2 study of Head and Neck Cancer, sponsored by Genentech.
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. According to ClinicalTrials.gov, the official US trial registry.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2012-07 |
| Est. Completion | 2015-06 |
| Phase | Phase 2 |
What the finished NCT01577173 record still lists
NCT01577173 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (53% lower).
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 names 20 study sites across 17 states, led by 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.
Learn More About Clinical Trials
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Where NCT01577173's enrollment target sits among peer trials
122 72nd of 250 higher than 179 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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