We use cookies to provide you with a better experience. By clicking the Accept button, you are agreeing to our use of cookies in accordance with our Privacy Policy.
  • Patient Resources
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
    • Glossary
  • Professional Resources
    • Research Center Profiles
    • Industry Provider Profiles
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • Patient Education
    • SOPs
  • About Us
  • Contact Us
  • Advertise
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » FDA puts Immunomedics’ pancreatic cancer trial on hold

FDA puts Immunomedics’ pancreatic cancer trial on hold

September 23, 2011
CenterWatch Staff

Immunomedics, a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, been notified by the FDA that a partial clinical hold has been placed on the company’s phase Ib/II clinical trial of clivatuzumab tetraxetan in patients with advanced pancreatic cancer, due to the administration of an incorrect dose to a patient enrolled at one of its trial sites.

This decision by the FDA was not due to safety issues of the product, but was based on a single incident in which a patient undergoing retreatment following a prior successful therapy cycle was administered a yttrium-90 (Y-90) dose higher than prescribed. After this error was discovered, no further doses were given to the patient, who remains on study with no critical toxicity. To date, there have been approximately 360 doses of clivatuzumab tetraxetan labeled with Y-90 successfully and correctly administered to almost 100 patients.

In response to this development, Cynthia L. Sullivan, president and CEO of Immunomedics, said, "We are preparing the requested remediation documents for the agency to ensure that this single error by the radiopharmacy will not reoccur in our trial, so that the partial clinical hold can be lifted as soon as possible. We are also working closely with the FDA to ensure patients who are eligible for retreatment can go on to receive additional cycles of therapy, once the partial hold is lifted. The phase Ib/II study is now fully enrolled, so we are hopeful to continue retreatment cycles for those patients who may benefit from this experimental therapy."

United States Study Conduct

Upcoming Events

  • 16Dec

    Master the Regulatory Pathway for Cell & Gene Therapy Submissions: Strategies for Successful BLAs

Featured Products

  • Regenerative-medicine-steps-to-accelerate-development-pdf

    Regenerative Medicine: Steps to Accelerate Development — PDF

  • Clinical-trial-agreements-a-guide-to-key-words-and-phrases-pdf

    Clinical Trial Agreements: A Guide to Key Words and Phrases — PDF

Featured Stories

  • Patient-phsyician-consultation

    Giving Patients Back Their Voice in Clinical Trials

  • Ich_logo

    ICH Overhauls 22-Year-Old Clinical Studies Guideline

  • Survey_chart2019

    Sponsors, CROs Doing Better, Sites Say, But More Work Is Needed

New!

2019 Site Survey Reports

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy

Footer Logo

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

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2019. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing