(INCB 24360-210) A Randomized, Open-Label, Phase 2 Study of the IDO Inhibitor INCB024360 Versus Tamoxifen for Subjects with Biochemical-Recurrent-Only Epithelial Ovarian Cancer, Primary Peritoneal Carcinoma, or Fallopian Tube Cancer Following Complete Remission with First-Line Chemotherapy
This study is being done to find out if the investigational drug INCB024360 is safe and has helpful effects when given to women with ovarian cancer who have elevated CA125 (a marker in the blood used to track disease) and no evidence of disease (â??biochemical recurrent onlyâ??) after achieving complete remission with first-line chemotherapy. This study will measure how long women who take INCB024360 survive without disease recurrence after taking the drug, compared to those that take a hormonal therapy called tamoxifen.
- Must have increasing CA125 - Must have had a complete response to first-line therapy with platinum - CA125 must have been elevated at first diagnosis and then normalized - Need 2 consecutive CA125 measurements that are elevated above upper limit of normal 4 weeks apart
This is an outpatient study where women will be randomized to receive study drug or Tamoxifen. Both are oral drugs and the cycles are every 28 days.
12/05/2013 04:02 AM