FDA Recommends Lower Dose of Liver Cancer Drug in Clinical Trials
The Wall Street Journal reports that shares of ArQule declined by 22 percent after the Food and Drug Administration recommended that the company reduce the clinical trial doses of a drug meant to treat patients with hepatocellular carcinoma, a type of liver cancer.
The recommendation was made in response to low white blood cell counts being reported in clinical trial participants.
About Hepatocellular Carcinoma
- According to the U.S. National Library of Medicine, hepatocellular carcinoma is currently the most common liver cancer in the world.
- The majority of hepatocellular carcinoma cases are caused by hepatitis B and hepatitis C viral infections.
- Symptoms of the disease included abdominal pain, easy bruising and bleeding, enlarged abdomen, and jaundice.
- While drugs and chemotherapy may stop or reduce tumor growth, the cancer normally requires aggressive surgery or a liver transplant.
Details on the Tivantinib Clinical Trials
- Tivantinib was meant to be taken orally in order to slow or stop tumor growth.
- The drug was found to produce a high incidences of neutropenia, or low counts of white blood cells essential for fighting bacterial and fungal infections.
- As a result of the low white blood cell counts, the FDA Data Monitoring Committee recommended that study doses be reduced from 240 mg taken twice per day to 120 mg taken twice per day.
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.