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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 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 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 9 states.

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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

Colorectal Cancer Colon Cancer Rectal Cancer Metastatic Colorectal Cancer

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

558 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, categorized as Phase 1. The registered enrollment target is 202 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (87% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 9 distinct geographic areas - top geographies include 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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.