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NCT00237627 · ClinicalTrials.gov registry record · Phase 1
Doxorubicin Hydrochloride Liposome and Bortezomib in Treating Patients With Refractory Hematologic Cancer or Malignant Solid Tumor or Metastatic Breast Cancer
A Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 107
- Enrollment target
NCT00237627: Completed Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT00237627 is a Phase 1 study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 107 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00237627, a Phase 1 study, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 107 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving doxorubicin hydrochloride liposome together with bortezomib may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib when given together with doxorubicin hydrochloride liposome and to see how well they work in treating patients with refractory hematologic cancer or malignant solid tumor or metastatic breast cancer.
Primary Outcome
When the current dose level exceeds the MTD, the preceding dose-level will be considered to be the MTD if there have been six patients treated at that dose level. Otherwise, 3 additional patients will be treated at the presumed MTD. No further dose escalation will occur. MTD, like dose limiting toxicity (DLT), will be defined based on toxicities seen within the first cycle. Among the additional 3 patients enrolled in a cohort, if one or more DLT is observed, the MTD will be considered to have be
Interventions
- DRUG Doxil
- DRUG Velcade
- DRUG PS-341
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2001-05 |
| Est. Completion | 2010-01 |
| Phase | Phase 1 |
What the finished NCT00237627 record still lists
NCT00237627 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% higher).
The record links to 0 conditions, and to 3 interventions - of which Doxil is the first listed.
NCT00237627 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00237627 about?
NCT00237627 is a clinical study titled "Doxorubicin Hydrochloride Liposome and Bortezomib in Treating Patients With Refractory Hematologic Cancer or Malignant Solid Tumor or Metastatic Breast Cancer". RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell ...
What is the current status of trial NCT00237627?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 107 participants. The study started on 2001-05. Estimated completion is 2010-01.
What interventions are being tested in trial NCT00237627?
The interventions under investigation include: Doxil (DRUG), Velcade (DRUG), PS-341 (DRUG).
Who is sponsoring clinical trial NCT00237627?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00237627's enrollment target sits among peer trials
107 531st of 2000 higher than 1,470 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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