GTx Initiates Phase IIb Ostarine Clinical Trial for Cancer Cachexia
GTx announced that it has initiated a Phase IIb clinical trial evaluating Ostarine for the treatment of cancer cachexia.
Cachexia is a debilitating, progressive muscle-wasting condition manifested by unintentional weight loss, muscle weakness, anemia, fatigue and death. More than 50 percent of cancer patients develop cachexia, GTx said.
The randomized, double-blind, placebo-controlled study of muscle wasting will enroll 150 patients with non-small cell lung cancer, colorectal cancer, non-Hodgkin’s lymphoma or chronic lymphocytic leukemia. The clinical trial is being conducted at approximately 35 clinical sites in the U.S. and Argentina. Study participants are being randomized to receive placebo or Ostarine 1 or 3 mg for four months.
According to the company, the primary endpoint of the trial is the change in total lean body mass at 16 weeks. Secondary endpoints include functional performance and safety.
The company said it expects to report top line data in the summer of 2008.