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NCT00828074 · ClinicalTrials.gov registry record · Phase 1
Sorafenib and Vinorelbine in Treating Women With Stage IV Breast Cancer
A Phase 1 study, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
NCT00828074: Completed Phase 1 study, sponsored by City of Hope Medical Center.
NCT00828074 is a Phase 1 study that has completed, run by City of Hope Medical Center. The registered enrollment target is 46 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00828074, a Phase 1 study, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
Study Summary
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with vinorelbine may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of sorafenib when given together with vinorelbine and to see how well they work in treating women with stage IV breast cancer.
Primary Outcome
Dose Limiting Toxicity (DLT) defined as any treatment-related grade 3 or greater non-hematologic toxicity (excluding alopecia, controllable nausea and vomiting, and serum triglycerides \< 1,500 mg/dL which recover within 1 week), grade 4 or greater thrombocytopenia, grade 4 or greater febrile neutropenia requiring hospitalization, or treatment delay of \> 2 weeks as a result of unresolved toxicity during the first cycle of therapy.
Interventions
- DRUG sorafenib tosylate
- DRUG vinorelbine ditartrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2008-11 |
| Est. Completion | 2014-04 |
| Phase | Phase 1 |
What the finished NCT00828074 record still lists
NCT00828074 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 2 interventions - of which sorafenib tosylate is the first listed.
NCT00828074 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00828074 about?
NCT00828074 is a clinical study titled "Sorafenib and Vinorelbine in Treating Women With Stage IV Breast Cancer". RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib t...
What is the current status of trial NCT00828074?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2008-11. Estimated completion is 2014-04.
What interventions are being tested in trial NCT00828074?
The interventions under investigation include: sorafenib tosylate (DRUG), vinorelbine ditartrate (DRUG).
Who is sponsoring clinical trial NCT00828074?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00828074's enrollment target sits among peer trials
46 1058th of 2000 higher than 935 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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