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COMPLETED Phase 1

Phase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal Cancer

NCT00625651 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 202 participants
Start Date 2007-10
Est. Completion 2011-09
Phase Phase 1

Sponsor

Amgen

266 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00625651

The ClinicalTrials.gov registry entry for NCT00625651 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 202 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 266 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00625651 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00625651?

The interventions under investigation include: Bevacizumab (DRUG), Placebo (DRUG), AMG 655 (DRUG), Modified FOLFOX6 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00625651?

This trial is sponsored by Amgen, which has 266 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial