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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. 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00095459
The ClinicalTrials.gov registry entry for NCT00095459 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 57 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.
NCT00095459 reports 0 study locations.
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.
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