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NCT00095459 · ClinicalTrials.gov registry record · Phase 1
BAY 43-9006 (Sorafenib) and Bevacizumab (Avastin) To Treat Solid Tumors
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
NCT00095459: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00095459 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 57 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00095459, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
Study Summary
Background: * BAY 43-9006 is an inhibitor of wild-type and mutant B-Raf and c-Raf kinase isoforms in vitro, but it also inhibits p38, c-kit, VEGFR-2 and PDGFR-Beta affecting tumor growth as well as possibly promoting apoptosis by events downstream of c-Raf. * Bevacizumab is a humanized IgG1 monoclonal antibody (MAb) that binds all biologically active isoforms of human vascular endothelial growth factor (VEGF, or VEGF-A) with high affinity (k(d)= 1.1nM) * The most common adverse events associated with bevacizumab of any severity include asthenia, pain, headache, hypertension, diarrhea, stomatitis, constipation, epistaxis, dyspnea, dermatitis and proteinuria. * This Phase I trial is open to patients with all solid tumors. Objectives: * Determine the safety and toxicity of the combination of BAY 43-9006 (Sorafenib) and bevacizumab. * Determine estimates of biochemical changes in the Ras-Raf-MAPK and VEGF signal transduction pathways in tumor and stromal cells in response to treatment at the MTD, at least in a pilot fashion, if those changes are statistically significant. Eligibility: * Adults with histologically documented solid tumor malignancy that is metastatic or unresectable and for which standard curative therapies do not exist or are no longer effective. * Patients must be off prior chemotherapy, radiation therapy, hormonal therapy, or biological therapy for at least 4 weeks. * All patients enrolling in cohort 2 must have at least one lesion amenable to biopsy. * ECOG performance status 0 or 1 and adequate organ and marrow function. Design: * Cohort I will receive BAY 43-9006 and bevacizumab together at the start of study in a dose escalation fashion. * Cohort II will be randomized as to which agent they receive for cycle one. Cycles 2 and beyond are treated using both agents. * Tumor biopsies will be obtained from patients in Cohort II before treatment, two weeks into mono-therapy, and two weeks into combinatorial therapy. * DCE-MRI studies will be obtai
Interventions
- DRUG Bevacizumab
- DRUG BAY 43-9006
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2004-11-02 |
| Est. Completion | 2012-07-20 |
| Phase | Phase 1 |
What the finished NCT00095459 record still lists
NCT00095459 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Bevacizumab is the first listed.
NCT00095459 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00095459 about?
NCT00095459 is a clinical study titled "BAY 43-9006 (Sorafenib) and Bevacizumab (Avastin) To Treat Solid Tumors". Background: * BAY 43-9006 is an inhibitor of wild-type and mutant B-Raf and c-Raf kinase isoforms in vitro, but it also inhibits p38, c-kit, VEGFR-2 and PDGFR-Beta affecting tumor growth as well as possibly promoting apoptosis by events downstream of c-Raf. * Bevacizumab is a humanized IgG1 monoclo...
What is the current status of trial NCT00095459?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2004-11-02. Estimated completion is 2012-07-20.
What interventions are being tested in trial NCT00095459?
The interventions under investigation include: Bevacizumab (DRUG), BAY 43-9006 (DRUG).
Who is sponsoring clinical trial NCT00095459?
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 NCT00095459's enrollment target sits among peer trials
57 901st of 2000 higher than 1,099 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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