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.
