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NCT01133678 · ClinicalTrials.gov registry record · Phase 2
Study in Locally Advanced Squamous Cell Carcinoma of Head and Neck
A Phase 2 study, sponsored by University of Chicago.
- Terminated
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT01133678: Clinical Trial Phase 2 study, sponsored by University of Chicago.
NCT01133678 is a Phase 2 study that was terminated before completion, run by University of Chicago. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01133678, a Phase 2 study, was terminated before completion, sponsored by University of Chicago.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
Primary Compare response rates (relative change in tumor size) to induction chemotherapy consisting of cisplatin/paclitaxel/cetuximab +/- everolimus. Secondary: Determine the maximum administered dose (MAD), maximum tolerated dose (MTD), dose limiting toxicity (DLT), and safety of everolimus with cisplatin/paclitaxel/cetuximab induction chemotherapy (phase I portion)
Primary Outcome
Change in tumor size (sum of longest diameters of target lesions) after two cycles of induction therapy, expressed as log of ratio of post-treatment to baseline measure.
Interventions
- DRUG Placebo
- DRUG Everolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2010-05-04 |
| Est. Completion | 2015-01 |
| Phase | Phase 2 |
Why NCT01133678 stopped before completion
NCT01133678 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01133678 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01133678 about?
NCT01133678 is a clinical study titled "Study in Locally Advanced Squamous Cell Carcinoma of Head and Neck". Primary Compare response rates (relative change in tumor size) to induction chemotherapy consisting of cisplatin/paclitaxel/cetuximab +/- everolimus. Secondary: Determine the maximum administered dose (MAD), maximum tolerated dose (MTD), dose limiting toxicity (DLT), and safety of everolimus with...
What is the current status of trial NCT01133678?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2010-05-04. Estimated completion is 2015-01.
What interventions are being tested in trial NCT01133678?
The interventions under investigation include: Placebo (DRUG), Everolimus (DRUG).
Who is sponsoring clinical trial NCT01133678?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01133678's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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