A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
ID Number 13-0518Principal Investigator(s)
Department(s) or Division(s)
Obstetrics, Gynecology, and Reproductive Science
The purpose of this study is to find out more about an experimental drug called AMG 386 in people with advanced epithelial ovarian, primary peritoneal or fallopian tube cancers. The purpose of this research is to see if the treatment with paclitaxel and carboplatin (approved chemotherapy) plus AMG 386 followed by 18 months of AMG 386 continued after the chemotherapy works better than treatment with paclitaxel and carboplatin plus placebo followed by 18 months of placebo in the first treatment of subjects with these cancers.
AMG 386 is a man-made drug being designed to stop the development of blood vessels in cancer tissues in order to stop the growth of the cancer. AMG 386 is considered experimental (or investigational) because it is not approved by the United States Food and Drug Administration (FDA) for use except in research. AMG 386 is not approved to treat any type of cancer.
Some subjects will receive placebo, which is an inactive (dummy) drug that will look like and be given in the same way as the AMG 386 active drug, but the placebo has no drug in it.
Recruiting Patients: Yes