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NCT01633541 · ClinicalTrials.gov registry record · Phase 2
Chemotherapy AND Bcl-xL Inhibitor (AT-101) For Organ Preservation In Adults With Advanced Laryngeal Cancer
A Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
NCT01633541: Completed Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
NCT01633541 is a Phase 2 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 55 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01633541, a Phase 2 study, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
Study Summary
To evaluate a new treatment approach for adults with advanced laryngeal cancer: induction chemotherapy with platinum and docetaxel plus AT-101. AT-101 is an investigational drug for the treatment of advanced cancer. It is hoped that the combination of this chemotherapy regimen will allow cancer patients to keep their voice box and to improve/maintain voice-related quality of life. The ultimate goal of this study is to prevent the surgery to remove subjects voice box.
Primary Outcome
The primary clinical objective of this trial is to compare the larynx preservation rates in a treatment paradigm that uses induction chemotherapy plus AT-101 to select patients for either concurrent chemoradiation or surgery. Organ preservation rate, defined as alive and free from indication for laryngectomy three months post treatment, was chosen as the primary endpoint because it provides evidence to fully characterize clinically the effect of the treatment strategy
Interventions
- DRUG Carboplatin
- DRUG Docetaxel
- DRUG Cisplatin
- DRUG AT-101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2012-03 |
| Est. Completion | 2021-11-06 |
| Phase | Phase 2 |
What the finished NCT01633541 record still lists
NCT01633541 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.
NCT01633541 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01633541 about?
NCT01633541 is a clinical study titled "Chemotherapy AND Bcl-xL Inhibitor (AT-101) For Organ Preservation In Adults With Advanced Laryngeal Cancer". To evaluate a new treatment approach for adults with advanced laryngeal cancer: induction chemotherapy with platinum and docetaxel plus AT-101. AT-101 is an investigational drug for the treatment of advanced cancer. It is hoped that the combination of this chemotherapy regimen will allow cancer pati...
What is the current status of trial NCT01633541?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2012-03. Estimated completion is 2021-11-06.
What interventions are being tested in trial NCT01633541?
The interventions under investigation include: Carboplatin (DRUG), Docetaxel (DRUG), Cisplatin (DRUG), AT-101 (DRUG).
Who is sponsoring clinical trial NCT01633541?
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 NCT01633541's enrollment target sits among peer trials
55 1153rd of 2000 higher than 841 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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