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NCT00867321 · ClinicalTrials.gov registry record · Phase 1
Bevacizumab and Sorafenib as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Liver Cancer
A Phase 1 study, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT00867321: Completed Phase 1 study, sponsored by Alliance for Clinical Trials in Oncology.
NCT00867321 is a Phase 1 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00867321, a Phase 1 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and sorafenib may also stop the growth of liver cancer by blocking blood flow to the tumor. PURPOSE: This randomized phase I/II trial is studying the best dose of bevacizumab when given together with sorafenib as first-line therapy in treating patients with locally advanced or metastatic liver cancer.(Phase I closed to accrual as of 11/03/2010)
Primary Outcome
MTD is defined as the dose level below the lowest dose that induces dose limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients). If dose level (-1) is not tolerable, but dose (-3) or (-2) is below or at MTD, testing of alternate dose levels (-2a, -3a, -3b) will occur as outlined in the table. The number of dose limiting toxicities will be reported here.
Interventions
- BIOLOGICAL bevacizumab
- DRUG sorafenib tosylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2009-04 |
| Est. Completion | 2013-05 |
| Phase | Phase 1 |
What the finished NCT00867321 record still lists
NCT00867321 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which bevacizumab is the first listed.
NCT00867321 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00867321 about?
NCT00867321 is a clinical study titled "Bevacizumab and Sorafenib as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Liver Cancer". RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sorafenib may stop the growth of tumor cells by blocking so...
What is the current status of trial NCT00867321?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2009-04. Estimated completion is 2013-05.
What interventions are being tested in trial NCT00867321?
The interventions under investigation include: bevacizumab (BIOLOGICAL), sorafenib tosylate (DRUG).
Who is sponsoring clinical trial NCT00867321?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00867321's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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