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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: Completed Phase 2 study, sponsored by Eastern Cooperative Oncology Group.
NCT00064350 is a Phase 2 study that has completed, run by Eastern Cooperative Oncology Group. The registered enrollment target is 342 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (157% higher). According to ClinicalTrials.gov, the official US trial registry.
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 That is, tumor growth is suspended while the drug is administered but returns to baseline rates when the agent is withdrawn.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.
Primary Outcome
Per RECIST Criteria (V1.0): Complete Response (CR): disappearance of all target lesions Partial Response (PR): \>=30% decrease in the sum of the longest diameter of target lesions Progressive Disease (PD): \>=20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of longest diameter recorded since randomization, or the appearance of new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify
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 |
What the finished NCT00064350 record still lists
NCT00064350 is an interventional study that assigns participants to a tested intervention. The registered 342 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (157% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00064350 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00064350's enrollment target sits among peer trials
342 136th of 2000 higher than 1,864 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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