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NCT01285635 · ClinicalTrials.gov registry record · Phase 2
A Study of AT-101 in Combination With Docetaxel in Squamous Cell Carcinoma Of The Head and Neck
A Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT01285635: Clinical Trial Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
NCT01285635 is a Phase 2 study that was terminated before completion, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01285635, a Phase 2 study, was terminated before completion, sponsored by University of Michigan Rogel Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
This study will examine the effects of an investigational drug called AT-101 in combination with an FDA approved cancer drug called Docetaxel. It is hoped that AT-101 will help the Docetaxel to have a better effect in slowing or stopping cancer cell growth. This study will help the researchers learn what effects, if any, the combination of AT-101 and Docetaxel has on your cancer. For instance, will the combination cause your tumor(s) to shrink or stop growing? The researchers will also learn about the safety of the combination of AT-101 and Docetaxel. For instance, are there any side effects? If so, what kind of side effects does the combination cause? How severe are the side effects, and how often do they occur?
Primary Outcome
The primary objective is to estimate the proportion of patients with a complete response (CR) and partial response(PR) defined by RECIST (Response Evaluation Criteria in Solid Tumors). CR is defined as the disappearance of all target lesions and PR is defined as at least a 20% decrease in the sum of the longest diameter of target lesions.
Interventions
- DRUG Docetaxel
- DRUG AT-101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2010-06 |
| Est. Completion | 2015-09 |
| Phase | Phase 2 |
Why NCT01285635 stopped before completion
NCT01285635 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which Docetaxel is the first listed.
NCT01285635 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01285635 about?
NCT01285635 is a clinical study titled "A Study of AT-101 in Combination With Docetaxel in Squamous Cell Carcinoma Of The Head and Neck". This study will examine the effects of an investigational drug called AT-101 in combination with an FDA approved cancer drug called Docetaxel. It is hoped that AT-101 will help the Docetaxel to have a better effect in slowing or stopping cancer cell growth. This study will help the researchers learn...
What is the current status of trial NCT01285635?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2010-06. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01285635?
The interventions under investigation include: Docetaxel (DRUG), AT-101 (DRUG).
Who is sponsoring clinical trial NCT01285635?
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 NCT01285635's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 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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