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NCT00411671 · ClinicalTrials.gov registry record · Phase 2
BATTLE Program: Sorafenib in Patients With NSCLC
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 105
- Enrollment target
NCT00411671: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00411671 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 105 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00411671, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 105 participants
- Enrollment target
Study Summary
Primary Objective: * To determine the 8 week progression-free survival rate (i.e. disease control rate) in patients with advanced non-small cell lung cancer (NSCLC) who have failed at least one prior chemotherapy regimen. Secondary Objective: The secondary objectives of this study will be to: * Determine the overall response rate * Determine the overall survival * Determine the time to disease progression * Assess the safety/toxicity of the study treatment * Assess biomarker modulation in the tumor tissue and serum samples from the treatment. * Assess plasma and intra-tumor concentrations of study treatment
Primary Outcome
The disease control rate (DCR) was defined as the proportion of patients who did not meet Response Evaluation Criteria in Solid Tumors (RECIST) criteria for progressive disease (PD) at 8 weeks. Progressive disease was defined as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Interventions
- DRUG Sorafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2006-11 |
| Est. Completion | 2012-11 |
| Phase | Phase 2 |
What the finished NCT00411671 record still lists
NCT00411671 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% lower).
The record links to 0 conditions, and to 1 intervention - of which Sorafenib is the first listed.
NCT00411671 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00411671 about?
NCT00411671 is a clinical study titled "BATTLE Program: Sorafenib in Patients With NSCLC". Primary Objective: * To determine the 8 week progression-free survival rate (i.e. disease control rate) in patients with advanced non-small cell lung cancer (NSCLC) who have failed at least one prior chemotherapy regimen. Secondary Objective: The secondary objectives of this study will be to: * ...
What is the current status of trial NCT00411671?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2006-11. Estimated completion is 2012-11.
What interventions are being tested in trial NCT00411671?
The interventions under investigation include: Sorafenib (DRUG).
Who is sponsoring clinical trial NCT00411671?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00411671's enrollment target sits among peer trials
105 650th of 2000 higher than 1,341 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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