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NCT00865709 · ClinicalTrials.gov registry record · Phase 2
Study of Modified FOLFOX6 Plus or Minus Sorafenib in Stage IV Metastatic Colorectal Carcinoma (mCRC) Subjects
A Phase 2 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 198
- Enrollment target
NCT00865709: Completed Phase 2 study, sponsored by Bayer.
NCT00865709 is a Phase 2 study that has completed, run by Bayer. The registered enrollment target is 198 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00865709, a Phase 2 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 198 participants
- Enrollment target
Study Summary
To determine if sorafenib when added to chemotherapy will slow disease progression more than chemotherapy alone in patients previously untreated for metastatic colorectal cancer.
Primary Outcome
Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression or death due to any cause, whichever occurred first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation. Disease progression was defined as an increase of at least 20% in the sum of tumor lesions sizes.
Interventions
- DRUG Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin)
- DRUG Matching placebo + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 198 participants |
| Start Date | 2009-03 |
| Est. Completion | 2012-02 |
| Phase | Phase 2 |
What the finished NCT00865709 record still lists
NCT00865709 is an interventional study that assigns participants to a tested intervention. The registered 198 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 (49% higher).
The record links to 0 conditions, and to 2 interventions - of which Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin) is the first listed.
NCT00865709 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00865709 about?
NCT00865709 is a clinical study titled "Study of Modified FOLFOX6 Plus or Minus Sorafenib in Stage IV Metastatic Colorectal Carcinoma (mCRC) Subjects". To determine if sorafenib when added to chemotherapy will slow disease progression more than chemotherapy alone in patients previously untreated for metastatic colorectal cancer.
What is the current status of trial NCT00865709?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 198 participants. The study started on 2009-03. Estimated completion is 2012-02.
What interventions are being tested in trial NCT00865709?
The interventions under investigation include: Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin) (DRUG), Matching placebo + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin) (DRUG).
Who is sponsoring clinical trial NCT00865709?
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 NCT00865709's enrollment target sits among peer trials
198 349th of 2000 higher than 1,652 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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