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NCT00581360 · ClinicalTrials.gov registry record · Phase 2
Phase II Trial of Doxorubicin and Bortezomib in Patients With Incurable Adenoid Cystic Carcinoma of the Head and Neck
A Phase 2 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT00581360: Completed Phase 2 study, sponsored by University of Pittsburgh.
NCT00581360 is a Phase 2 study that has completed, run by University of Pittsburgh. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00581360, a Phase 2 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
This is a Phase II trial non-randomized study to evaluate the objective response rate and stable disease rate (primary endpoints), progression-free survival, overall survival and toxicities with the combination of doxorubicin and bortezomib in patients with incurable head and neck adenoid cystic carcinoma. Also, we plan to collect tumor tissue from previous diagnostic procedures and baseline blood specimens for future correlative studies.
Primary Outcome
ORR is the number participants experiencing partial response (PR) + the number participants experiencing complete response (CR) / the number participants experiencing partial response (PR) + the number participants experiencing complete response (CR) + the number participants experiencing stable disease (SD) + the number participants experiencing progressive disease (PD). RECIST v1.0 criteria for Target Lesions was used: Complete Response (CR): Disappearance of all target lesions; Partial Respon
Interventions
- DRUG doxorubicin and bortezomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2007-11 |
| Est. Completion | 2011-06 |
| Phase | Phase 2 |
What the finished NCT00581360 record still lists
NCT00581360 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which doxorubicin and bortezomib is the first listed.
NCT00581360 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00581360 about?
NCT00581360 is a clinical study titled "Phase II Trial of Doxorubicin and Bortezomib in Patients With Incurable Adenoid Cystic Carcinoma of the Head and Neck". This is a Phase II trial non-randomized study to evaluate the objective response rate and stable disease rate (primary endpoints), progression-free survival, overall survival and toxicities with the combination of doxorubicin and bortezomib in patients with incurable head and neck adenoid cystic car...
What is the current status of trial NCT00581360?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2007-11. Estimated completion is 2011-06.
What interventions are being tested in trial NCT00581360?
The interventions under investigation include: doxorubicin and bortezomib (DRUG).
Who is sponsoring clinical trial NCT00581360?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00581360's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 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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