FDA Halts Enrollment for Curis Clinical Drug Trial after Patient Death

The U.S. Food and Drug Administration has placed a partial hold on a clinical trial for an experimental cancer drug developed by Curis Inc. following the death of one of the study’s patients.

Experimental Cancer Drug Linked to Liver Problems

  • According to Reuters, Curis was testing its experimental drug CUDC-427 on patients with advanced solid tumors and lymphoma.
  • In the trial, patients were given CUDC-427 twice daily as researchers attempted to access the safety, maximum tolerable dose and efficacy of the drug.
  • One patient with advanced breast cancer developed serious adverse events related to liver function and was taken off the drug.
  • The patient died about a month after treatment was halted.

FDA Seeking more Information

  • A release by Curis stated that the FDA is seeking more data on the patient involved in the CUDC-427 clinical trial.
  • As the FDA gathers the data, Curis is barred from enrolling any new patients into the clinical trial.
  • Information from ClinicalTrials.gov shows trials were being conducted in Nashville, Tennessee and San Antonio, Texas.
Contact an Experienced Clinical Trial Attorney

Thomas J. Henry are leaders in the area clinical trial litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. Our Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/or defective pharmaceuticals.

If you or a loved one have been injured by or have developed serious side-effects while participating in a clinical trial, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.

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