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NCT00625651 · ClinicalTrials.gov registry record · Phase 1
Phase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal Cancer
A Phase 1 study of Colorectal Cancer and Colon Cancer, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 202
- Enrollment target
- 20
- Study locations
NCT00625651: Completed Phase 1 study of Colorectal Cancer and Colon Cancer, sponsored by Amgen.
NCT00625651 is a Phase 1 study of Colorectal Cancer and Colon Cancer that has completed, run by Amgen. The registered enrollment target is 202 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00625651, a Phase 1 study of Colorectal Cancer and Colon Cancer, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 202 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase 1/2, multi-center, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AMG 655 when combined with mFOLFOX6 and bevacizumab compared with mFOLFOX6 and bevacizumab alone in subjects with previously untreated metastatic colorectal cancer (CRC). The clinical benefit of AMG 655 in combination with mFOLFOX6 and bevacizumab will be measured by progression-free survival, objective response rate, time to response, duration of response, and overall survival. This study is also designed to evaluate the safety and tolerability of AMG 655 in combination with mFOLFOX6 and bevacizumab and to evaluate anti-AMG 655 antibody formation and the pharmacokinetics of AMG 655.
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG Placebo
- DRUG AMG 655
- DRUG Modified FOLFOX6
Study Locations (20)
California
- Research Site - Downey
- Research Site - La Jolla
- Research Site - Loma Linda
- Research Site - Orange
- Research Site - Rancho Mirage
- Research Site - San Diego
Florida
- Research Site - Boca Raton
- Research Site - Kissimmee
- Research Site - Leesburg
- Research Site - Miami
- Research Site - Miami
Georgia
- Research Site - Atlanta
- Research Site - Lawrenceville
Illinois
- Research Site - Harvey
- Research Site - Maywood
Arkansas
- Research Site - Hot Springs
Colorado
- Research Site - Denver
Delaware
- Research Site - Newark
District of Columbia
- Research Site - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2007-10 |
| Est. Completion | 2011-09 |
| Phase | Phase 1 |
What the finished NCT00625651 record still lists
NCT00625651 is an interventional study that assigns participants to a tested intervention. The registered 202 participants enrollment target is mid-sized for trials with a published cap, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (87% lower).
The record links to 4 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 4 interventions - of which Bevacizumab is the first listed.
NCT00625651 names 20 study sites across 9 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT00625651 about?
NCT00625651 is a clinical study titled "Phase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal Cancer". This phase 1/2, multi-center, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AMG 655 when combined with mFOLFOX6 and bevacizumab compared with mFOLFOX6 and bevacizumab alone in subjects with previously untreated metastatic colorectal cancer (CRC...
What is the current status of trial NCT00625651?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 202 participants. The study started on 2007-10. Estimated completion is 2011-09.
What conditions does trial NCT00625651 study?
This clinical trial studies the following conditions: Colorectal Cancer, Colon Cancer, Rectal Cancer, Metastatic Colorectal Cancer.
What interventions are being tested in trial NCT00625651?
The interventions under investigation include: Bevacizumab (DRUG), Placebo (DRUG), AMG 655 (DRUG), Modified FOLFOX6 (DRUG).
Who is sponsoring clinical trial NCT00625651?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00625651 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Delaware, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00625651's enrollment target sits among peer trials
202 146th of 381 higher than 236 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer 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.
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