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NCT00436215 · ClinicalTrials.gov registry record · Phase 2
Sorafenib and Bevacizumab to Treat Ovarian, Fallopian and Peritoneal Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
NCT00436215: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00436215 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 55 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00436215, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
Study Summary
Background: * Sorafenib and bevacizumab are anti-cancer drugs that work by targeting the blood vessels that allow tumors to grow. Using the two drugs together may more effectively block the formation of blood vessels that feed tumors. * Sorafenib and bevacizumab both are approved by the Food and Drug Administration for use in other cancers but have not ovarian cancer. In a preliminary trial of this drug combination, however, tumors in 6 of 14 patients with ovarian cancer shrank. Objectives: * To determine the safety and activity of the combination of sorafenib and bevacizumab for treating patients with ovarian, fallopian and peritoneal cancer. * To determine how sorafenib and bevacizumab may affect the cancer by measuring amounts of different proteins in small biopsy samples of tumor taken before starting treatment and after 6 weeks. Eligibility: * Females 18 years of age and older with ovarian, fallopian, or peritoneal cancer whose disease has not responded to standard treatment or for which no standard treatment is available. * Patients must have not been previously treated with bevacizumab or must have had their disease worsen while taking bevacizumab-based therapy. Design: * Patients take 200 mg of sorafenib by mouth twice a day Monday through Friday each week and 5 mg/kg of bevacizumab through a vein every 2 weeks. * Tumor biopsies and imaging scans (magnetic resonance imaging (MRI) and positron emission tomography (PET) are done before treatment, 3 days after beginning treatment, and 6 weeks into therapy. * Computed tomography (CT) or other imaging tests are done every 8 weeks to evaluate response to treatment. * History, physical examinations, blood and urine tests are done periodically during treatment for health checks and research purposes. * About 74 patients are to be enrolled in the trial.
Primary Outcome
Clinical response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) per the Response Evaluation Criteria in Solid Tumors (RECIST). CR is disappearance of all target lesions. PR is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the
Interventions
- DRUG Bevacizumab
- DRUG BAY 43-9006
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2006-12-12 |
| Est. Completion | 2014-09-27 |
| Phase | Phase 2 |
What the finished NCT00436215 record still lists
NCT00436215 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 2 interventions - of which Bevacizumab is the first listed.
NCT00436215 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00436215 about?
NCT00436215 is a clinical study titled "Sorafenib and Bevacizumab to Treat Ovarian, Fallopian and Peritoneal Cancer". Background: * Sorafenib and bevacizumab are anti-cancer drugs that work by targeting the blood vessels that allow tumors to grow. Using the two drugs together may more effectively block the formation of blood vessels that feed tumors. * Sorafenib and bevacizumab both are approved by the Food and Dr...
What is the current status of trial NCT00436215?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2006-12-12. Estimated completion is 2014-09-27.
What interventions are being tested in trial NCT00436215?
The interventions under investigation include: Bevacizumab (DRUG), BAY 43-9006 (DRUG).
Who is sponsoring clinical trial NCT00436215?
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 NCT00436215's enrollment target sits among peer trials
55 1153rd of 2000 higher than 841 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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