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NCT00825734 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Trial of Sorafenib Plus Ixabepilone in HER2-Negative Metastatic Breast Cancer
A Phase 1 study, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 1
- Development phase
- 83
- Enrollment target
NCT00825734: Completed Phase 1 study, sponsored by SCRI Development Innovations.
NCT00825734 is a Phase 1 study that has completed, run by SCRI Development Innovations. The registered enrollment target is 83 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00825734, a Phase 1 study, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 83 participants
- Enrollment target
Study Summary
In this study, patients with metastatic HER2-negative breast cancer will receive treatment with ixabepilone and sorafenib until disease progression or unacceptable toxicity occurs. The Phase I portion of this study will determine the maximum tolerated doses (MTDs) of sorafenib and ixabepilone that may be used in combination for first- or second-line treatment of MBC. The MTDs identified in the Phase I portion of the study will be used in the Phase II portion which will evaluate the efficacy and safety of the combination of sorafenib and ixabepilone in patients who have received at least one prior chemotherapy treatment in either the adjuvant or neoadjuvant setting or following one prior MBC chemotherapy in MBC patients who had not received prior adjuvant or neoadjuvant breast cancer chemotherapy. This will be one of the initial trials investigating the use of this treatment combination for MBC. This trial will be conducted under the leadership of the Sarah Cannon Research Institute (SCRI) Oncology Research Consortium, a community-based, multi-center, clinical trial organization.
Primary Outcome
Measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) - progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Interventions
- DRUG Sorafenib
- DRUG Ixabepilone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2009-03 |
| Est. Completion | 2014-08 |
| Phase | Phase 1 |
What the finished NCT00825734 record still lists
NCT00825734 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% higher).
The record links to 0 conditions, and to 2 interventions - of which Sorafenib is the first listed.
NCT00825734 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00825734 about?
NCT00825734 is a clinical study titled "Phase I/II Trial of Sorafenib Plus Ixabepilone in HER2-Negative Metastatic Breast Cancer". In this study, patients with metastatic HER2-negative breast cancer will receive treatment with ixabepilone and sorafenib until disease progression or unacceptable toxicity occurs. The Phase I portion of this study will determine the maximum tolerated doses (MTDs) of sorafenib and ixabepilone that m...
What is the current status of trial NCT00825734?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 83 participants. The study started on 2009-03. Estimated completion is 2014-08.
What interventions are being tested in trial NCT00825734?
The interventions under investigation include: Sorafenib (DRUG), Ixabepilone (DRUG).
Who is sponsoring clinical trial NCT00825734?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00825734's enrollment target sits among peer trials
83 665th of 2000 higher than 1,332 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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