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NCT00911170 · ClinicalTrials.gov registry record · Phase 3
PAVES: Pegfilgrastim Anti-vascular Endothelial Growth Factor (VEGF) Evaluation Study
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 847
- Enrollment target
NCT00911170 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 847 participants.
The verdict
NCT00911170, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 847 participants
- Enrollment target
Study Summary
This is a phase 3, randomized, double-blind, placebo-controlled multi-center study evaluating the efficacy of pegfilgrastim to reduce the incidence of febrile neutropenia (FN) in patients with newly diagnosed, locally-advanced or metastatic colorectal cancer receiving first-line treatment with bevacizumab and either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI). This study will also investigate the effect of adding pegfilgrastim to bevacizumab and either FOLFOX or FOLFIRI by evaluating overall survival, progression-free survival, and overall response rate in each arm at regular intervals over a maximum of 60 months follow-up.
Interventions
- DRUG Placebo
- BIOLOGICAL Bevacizumab
- DRUG Standard Chemotherapy
- DRUG Pegfilgrastim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 847 participants |
| Start Date | 2009-11-03 |
| Est. Completion | 2015-01-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00911170
The ClinicalTrials.gov registry entry for NCT00911170 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 847 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00911170 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00911170 about?
NCT00911170 is a clinical study titled "PAVES: Pegfilgrastim Anti-vascular Endothelial Growth Factor (VEGF) Evaluation Study". This is a phase 3, randomized, double-blind, placebo-controlled multi-center study evaluating the efficacy of pegfilgrastim to reduce the incidence of febrile neutropenia (FN) in patients with newly diagnosed, locally-advanced or metastatic colorectal cancer receiving first-line treatment with bevac...
What is the current status of trial NCT00911170?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 847 participants. The study started on 2009-11-03. Estimated completion is 2015-01-02.
What interventions are being tested in trial NCT00911170?
The interventions under investigation include: Placebo (DRUG), Bevacizumab (BIOLOGICAL), Standard Chemotherapy (DRUG), Pegfilgrastim (DRUG).
Who is sponsoring clinical trial NCT00911170?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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