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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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). 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
Primary Outcome
The time between the first day of treatment to the day of disease progression. Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST). Progression is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
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 |
What the finished NCT00923130 record still lists
NCT00923130 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Bevacizumab is the first listed.
NCT00923130 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00923130's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 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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