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.

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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.