A Phase 3, Randomized, Double-Blind Trial of Pegylated Liposomal Doxorubicin (PLD) Plus AMG 386 or Placebo in Women with Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
ID Number 11-1216Principal Investigator(s)
Department(s) or Division(s)
The purpose of this study is to evaluate whether AMG 386 in combination with pegylated liposomal doxorubicin (also called “PLD” chemotherapy) improves the outcome of treatment, compared to treatment with PLD chemotherapy alone. The study will be looking at these treatments in women with recurrent epithelial ovarian, primary peritoneal or fallopian tube cancers who have previously received a platinum-containing regimen.
AMG 386 is an investigational product, which means that it has not been approved by an appropriate regulatory agency (eg, United States Food and Drug Administration [FDA], the European Medicines Agency, Therapeutic Goods Administration [TGA]). You will also be asked to provide samples of your blood, previously removed tumor tissue, and any tumor collected during the study. The samples will be studied to look for special markers that can be used to tailor the use of AMG 386 in treating recurrent epithelial ovarian, primary peritoneal and fallopian tube cancer and/or to study that disease.
Recruiting Patients: Yes