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NCT00806286 · ClinicalTrials.gov registry record · Phase 2
Study of Carboplatin/Paclitaxel With or Without Investigational Drug (CS-7017) in Subjects With Metastatic Non-small Cell Lung Cancer
A Phase 2 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 2
- Development phase
- 111
- Enrollment target
NCT00806286: Completed Phase 2 study, sponsored by Daiichi Sankyo.
NCT00806286 is a Phase 2 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 111 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00806286, a Phase 2 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 111 participants
- Enrollment target
Study Summary
The study has a safety and a Phase 2 portion. In the safety portion of the study, subjects with metastatic non-small cell lung cancer will be treated with study drug (CS-7017) in combination with carboplatin and paclitaxel to evaluate safety. In the Phase 2 portion of the study, subjects will receive study drug (CS-7017) or placebo in combination with carboplatin and paclitaxel to evaluate effectiveness and safety. The study will find out if adding CS-7017 to carboplatin and paclitaxel will be safe and improve progression free survival in subjects with metastatic non-small cell lung cancer.
Primary Outcome
Progression-free survival (PFS) was defined as the time from the date of randomization to the earlier of the dates of the first objective documentation of disease progression (based upon radiographic tumor assessments) or death. As per Response Evaluation Criteria for Solid Tumors v1.0, disease progression was characterized as confirmed complete response (CR) defined as disappearance of all target lesions, confirmed partial response (PR) defined as ≥30% decrease from baseline, stable disease (SD
Interventions
- DRUG Carboplatin
- DRUG Paclitaxel
- DRUG Placebo Tablets
- DRUG CS7017 tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2008-12 |
| Est. Completion | 2012-08 |
| Phase | Phase 2 |
What the finished NCT00806286 record still lists
NCT00806286 is an interventional study that assigns participants to a tested intervention. The registered 111 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 (17% lower).
The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.
NCT00806286 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00806286 about?
NCT00806286 is a clinical study titled "Study of Carboplatin/Paclitaxel With or Without Investigational Drug (CS-7017) in Subjects With Metastatic Non-small Cell Lung Cancer". The study has a safety and a Phase 2 portion. In the safety portion of the study, subjects with metastatic non-small cell lung cancer will be treated with study drug (CS-7017) in combination with carboplatin and paclitaxel to evaluate safety. In the Phase 2 portion of the study, subjects will receiv...
What is the current status of trial NCT00806286?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 111 participants. The study started on 2008-12. Estimated completion is 2012-08.
What interventions are being tested in trial NCT00806286?
The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), Placebo Tablets (DRUG), CS7017 tablets (DRUG).
Who is sponsoring clinical trial NCT00806286?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00806286's enrollment target sits among peer trials
111 632nd of 2000 higher than 1,369 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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