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NCT00064350 · ClinicalTrials.gov registry record · Phase 2
Sorafenib in Treating Patients With Refractory Non-Small Cell Lung Cancer
A Phase 2 study, sponsored by Eastern Cooperative Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 342
- Enrollment target
NCT00064350 is a Phase 2 study that has completed, run by Eastern Cooperative Oncology Group. The registered enrollment target is 342 participants.
The verdict
NCT00064350, a Phase 2 study, has completed, sponsored by Eastern Cooperative Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 342 participants
- Enrollment target
Study Summary
RATIONALE: Preclinical studies indicate that sorafenib is a potent inhibitor of Raf kinase in vitro and in vivo, with significant dose-dependent, anti-tumor activity in four different human tumor types including colon, pancreatic, lung, and ovarian. This activity was cytostatic in nature and was maintained if dosing was continued. That is, tumor growth is suspended while the drug is administered but returns to baseline rates when the agent is withdrawn. Therefore, the optimal schedule will be an uninterrupted one. To assess the activity of sorafenib in a timely manner and with a meaningful interpretation, a randomized discontinuation design was adopted in the present trial, conducted in a population who were potentially sensitive to sorafenib. PURPOSE: This randomized phase II trial is studying sorafenib to see how well it works compared to placebo in treating patients with refractory non-small cell lung cancer.
Interventions
- DRUG Placebo
- DRUG Sorafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 342 participants |
| Start Date | 2004-06-28 |
| Est. Completion | 2011-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00064350
The ClinicalTrials.gov registry entry for NCT00064350 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 342 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eastern Cooperative Oncology Group, which has 141 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00064350 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00064350 about?
NCT00064350 is a clinical study titled "Sorafenib in Treating Patients With Refractory Non-Small Cell Lung Cancer". RATIONALE: Preclinical studies indicate that sorafenib is a potent inhibitor of Raf kinase in vitro and in vivo, with significant dose-dependent, anti-tumor activity in four different human tumor types including colon, pancreatic, lung, and ovarian. This activity was cytostatic in nature and was mai...
What is the current status of trial NCT00064350?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 342 participants. The study started on 2004-06-28. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00064350?
The interventions under investigation include: Placebo (DRUG), Sorafenib (DRUG).
Who is sponsoring clinical trial NCT00064350?
This trial is sponsored by Eastern Cooperative Oncology Group, which has 141 total clinical trials registered on ClinicalTrials.gov.
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