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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: Completed Phase 3 study, sponsored by Amgen.
NCT00911170 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 847 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Grade 3/4 febrile neutropenia (FN) is defined as: • A temperature ≥ 38.0°C (≥ 100.4°F) and absolute neutrophil count (ANC) \< 1.0 × 10\^9/L, where ANC was measured the same day or within ± 1 calendar day of a temperature ≥ 38.0°C (≥ 100.4°F), or • An ANC \< 1.0 × 10\^9/L in combination with: - documented sepsis or infection, OR - neutropenia-related hospitalization where ANC was measured the same day or within ± 1 calendar day. Participants monitored their oral temperatures and maintained diarie
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 |
What the finished NCT00911170 record still lists
NCT00911170 is an interventional study that assigns participants to a tested intervention. The registered 847 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00911170 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00911170's enrollment target sits among peer trials
847 390th of 2000 higher than 1,610 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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