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NCT01469546 · ClinicalTrials.gov registry record · Phase 2
Phase II Trial Evaluating Axitinib In Patients With Unresectable, Recurrent Or Metastatic Head And Neck Cancer
A Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT01469546: Completed Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
NCT01469546 is a Phase 2 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 42 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01469546, a Phase 2 study, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate a new agent Axitinib in the treatment of head and neck cancer. This is a new drug that is given as a pill twice a day to treat cancer. This is one of the new, "smart" drugs. It binds to a protein on the surface of the cancer cell called VEGFR, and this way it slows down the growth of cancer cells and kills them. Head and neck cancer cells are known to carry this protein on their surface. Research in animals and in patients with other kinds of cancer showed that Axitinib can be effective at killing cancer cells, or stopping their growth, by this mechanism. It is generally a safe drug that is given by mouth. The investigators do not know, however, whether Axitinib is effective in head and neck cancer. This research study is being conducted to learn if Axitinib works in head and neck cancer, and also to learn to predict who would benefit from it. Four blood draws will be done to check special blood tests while the subjects are treated with Axitinib. These will be drawn at the same time as your routine labs, and there will not be additional sticks needed. A biopsy of the tumor before and after 1 month of treatment may be obtained to test how the cancer cells are responding to treatment. By testing these blood and tissue samples, the researchers will look at special tests (protein molecules) to try to determine what kind of head and neck patients would best respond to this drug. This is an open-label study, meaning that all subjects are on the active drug and there is no placebo (sugar pill).
Primary Outcome
To determine the 6-months progression-free survival (PFS) rate in patients with unresectable recurrent and metastatic head and neck cancer treated with Axitinib.
Interventions
- DRUG Axitinib (AG-013736)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2012-01 |
| Est. Completion | 2016-03 |
| Phase | Phase 2 |
What the finished NCT01469546 record still lists
NCT01469546 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 1 intervention - of which Axitinib (AG-013736) is the first listed.
NCT01469546 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01469546 about?
NCT01469546 is a clinical study titled "Phase II Trial Evaluating Axitinib In Patients With Unresectable, Recurrent Or Metastatic Head And Neck Cancer". The purpose of this study is to investigate a new agent Axitinib in the treatment of head and neck cancer. This is a new drug that is given as a pill twice a day to treat cancer. This is one of the new, "smart" drugs. It binds to a protein on the surface of the cancer cell called VEGFR, and this wa...
What is the current status of trial NCT01469546?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2012-01. Estimated completion is 2016-03.
What interventions are being tested in trial NCT01469546?
The interventions under investigation include: Axitinib (AG-013736) (DRUG).
Who is sponsoring clinical trial NCT01469546?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01469546's enrollment target sits among peer trials
42 1339th of 2000 higher than 649 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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