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NCT00923130 · ClinicalTrials.gov registry record · Phase 2
Bevacizumab Plus Ixabepilone to Treat Patients With Advanced Kidney Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT00923130: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00923130 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00923130, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
Background: * Substantial preclinical antitumor synergy supports the exploration of the combination of antiangiogenic compounds (including sunitinib and bevacizumab) plus ixabepilone. In Vivo, synergistic activity between ixabepilone and bevacizumab has been demonstrated using the 151-B human renal carcinoma xenograft model and this synergy compares favorably with other antiangiogenic inhibitors (i.e. sunitinib). * Combination therapies of bevacizumab with chemotherapy demonstrated improved benefit compared with single-agent cytotoxics in multiple animal models and in humans. * Clinical activity of both compounds used as single agents has been demonstrated in a broad spectrum of solid tumors. Bevacizumab and ixabepilone, when used as a single agent, have demonstrated substantial activity in renal cell carcinoma. * Phase II studies with bevacizumab and ixabepilone suggest the absence of overlapping toxicities. * Development of a well-tolerated and active bevacizumab/ixabepilone combination has the potential to further improve the treatment of metastatic renal cell carcinoma (mRCC), and could represent a second-line option after sunitinib or sorafenib are no longer of benefit or are intolerable. Primary Objectives: * Determine the objective response rate of the combination of ixabepilone and bevacizumab in patients with relapsed or refractory mRCC. * Determine progression-free survival. * Characterize the toxicity of the combination of ixabepilone and bevacizumab in patients with mRCC. * Determine changes in biomarkers and evaluate correlation with clinical outcomes. Eligibility: * Pathologic confirmation of renal cell carcinoma (clear cell histology) by the Laboratory of Pathology, National Cancer Institute (NCI), or the Medical University of South Carolina. * Presence of metastatic renal carcinoma, after progression or intolerance to Vascular endothelial growth factor receptor (VEGFR) inhibitors (sunitinib and/or sorafenib). * Adequate organ and bone marrow fun
Interventions
- DRUG Bevacizumab
- DRUG Ixabepilone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2009-01-07 |
| Est. Completion | 2016-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00923130
The ClinicalTrials.gov registry entry for NCT00923130 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Bevacizumab is the first listed.
NCT00923130 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00923130 about?
NCT00923130 is a clinical study titled "Bevacizumab Plus Ixabepilone to Treat Patients With Advanced Kidney Cancer". Background: * Substantial preclinical antitumor synergy supports the exploration of the combination of antiangiogenic compounds (including sunitinib and bevacizumab) plus ixabepilone. In Vivo, synergistic activity between ixabepilone and bevacizumab has been demonstrated using the 151-B human renal...
What is the current status of trial NCT00923130?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2009-01-07. Estimated completion is 2016-06.
What interventions are being tested in trial NCT00923130?
The interventions under investigation include: Bevacizumab (DRUG), Ixabepilone (DRUG).
Who is sponsoring clinical trial NCT00923130?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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