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NCT00101413 · ClinicalTrials.gov registry record · Phase 2
BAY43-9006 - Phase II Study in Non-Small Cell Lung Carcinoma (NSCLC)
A Phase 2 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
NCT00101413: Completed Phase 2 study, sponsored by Bayer.
NCT00101413 is a Phase 2 study that has completed, run by Bayer. The registered enrollment target is 52 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00101413, a Phase 2 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate if BAY43-9006 has an effect on the tumors, how long the effect continues, if the patients receiving BAY43-9006 will live longer. * If BAY43-9006 has an effect on the quality of life of patients with non-small cell lung cancer. * If BAY43-9006 helps to slow the worsening of non-small cell lung cancer. * If BAY43-9006 prevents the growth of, or shrinks non-small cell lung tumors and/or their metastases.
Primary Outcome
CR-disappearance of clinical/radiological tumor evidence (target/nontarget). PR- \>=30% decrease in sum longest diameter (LD) of target lesions from BL sum LD. Stable disease (SD)-no shrinkage for PR nor increase for PD. Progressive disease (PD) measurement proven- \>=20% increase in sum LD of lesions from smallest sum LD since start or new lesions. Progression by clinical judgement- \>clinically meaningful cancer-related deterioration as judged by the investigator.
Interventions
- DRUG Sorafenib (Nexavar, BAY43-9006)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2004-04 |
| Est. Completion | 2008-04 |
| Phase | Phase 2 |
What the finished NCT00101413 record still lists
NCT00101413 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 1 intervention - of which Sorafenib (Nexavar, BAY43-9006) is the first listed.
NCT00101413 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00101413 about?
NCT00101413 is a clinical study titled "BAY43-9006 - Phase II Study in Non-Small Cell Lung Carcinoma (NSCLC)". The purpose of the study is to evaluate if BAY43-9006 has an effect on the tumors, how long the effect continues, if the patients receiving BAY43-9006 will live longer. * If BAY43-9006 has an effect on the quality of life of patients with non-small cell lung cancer. * If BAY43-9006 helps to slow th...
What is the current status of trial NCT00101413?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2004-04. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00101413?
The interventions under investigation include: Sorafenib (Nexavar, BAY43-9006) (DRUG).
Who is sponsoring clinical trial NCT00101413?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00101413's enrollment target sits among peer trials
52 1181st of 2000 higher than 811 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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