We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » HUMAN GENOME REPORTS RESULTS OF COLORECTAL CANCER STUDY

HUMAN GENOME REPORTS RESULTS OF COLORECTAL CANCER STUDY

November 2, 2005

Human Genome Sciences reported that the results of a Phase II clinical trial demonstrate that HGS-ETR1 (mapatumumab) is well-tolerated and can be administered safely in patients with advanced colorectal cancer.

The results were presented at the European Cancer Conference, being held in Paris. The trial, which was conducted in Germany, was an open-label study to evaluate the efficacy, safety and tolerability of HGS-ETR1 as monotherapy in patients with relapsed or refractory colorectal cancer. Data were presented on 38 patients with relapsed or refractory Stage IIIb, IV or recurrent colorectal cancer. Patients enrolled in the trial received up to six cycles of treatment in the absence of disease progression. HGS-ETR1 was administered as an intravenous infusion at 20 mg/kg at 14-day intervals in cycles 1 and 2, and at 10 mg/kg at 14-day intervals in cycles 3-6.

The primary objective of the study was to evaluate tumor response after every third treatment (approximately every six weeks). Safety and tolerability were assessed as secondary endpoints. Several additional indicators of disease activity also were evaluated, including time to response, duration of response, and progression-free survival. Plasma concentrations of HGS-ETR1 were determined for use in a population pharmacokinetic analysis.

KEYWORDS Drug Pipeline Alert

Upcoming Events

  • 10Mar

    FDA Drug GMP Facility Inspections During the Pandemic

  • 16Mar

    Pharmaceutical Naming Regulation: Understanding the Latest Developments

  • 18Mar

    Pharmaceutical Postmarket Surveillance: Latest Developments in the Era of COVID-19

  • 23Mar

    Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

  • 30Mar

    Data Integrity for GMP/Postmarket Professionals: Core Requirements, Expectations and Challenges

  • 06Apr

    Medical Device Cybersecurity: Understand the Latest Developments

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • Vaccine needle

    Turkish Researchers Downgrade Sinovac’s COVID-19 Vaccine Efficacy Rate

  • Luminex logo

    Luminex Receives EUA for Expanded Respiratory Pathogen Panel, Clearing It for COVID-19

  • Acquires -Acquired

    Amgen to Buy Five Prime Therapeutics for $1.9 Billion

  • abbott-logo.gif

    Abbott Secures EUA for COVID-19 Combination Test

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing