A Phase 3, Randomized, Double-Blind Trial of Weekly Paclitaxel Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
ID Number 12-1015
Principal Investigator(s)Konstantin Zakashansky
Department(s) or Division(s)
Gynecologic Oncology
Description
This study is testing a drug called AMG 386. The purpose of this study is to evaluate whether AMG 386 in combination with paclitaxel works better against the cancers being studied compared to treatment with paclitaxel alone. AMG 386 is an experimental drug, which means that it has not been approved by the United States Food and Drug Administration (FDA) for use except in research.
AMG 386 is a man-made drug designed to stop the development of blood vessels in cancer tissues to stop the cancer from growing. Paclitaxel (chemotherapy, brand names Taxol and Onxal) has been approved by the FDA for the treatment of recurrent epithelial ovarian, primary peritoneal or fallopian tube cancer. Some subjects will receive paclitaxel plus AMG 386 and some will receive paclitaxel plus placebo. Placebo is an inactive (dummy) drug that looks like AMG 386 but has no active drug in it.
You will also be asked to provide samples of your blood and previously removed tumor tissue(s). These samples will be studied to look for special markers that can be used to find out who might best benefit from AMG 386 and/or to study cancer.
Contact Information
Konstantin Zakashansky
(212) 427-9898
Recruiting Patients: No