GOG 3001: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of AMG386 with Paclitaxel and Carboplatin… Primary Peritoneal or Fallopian Tube Cancers (Protocol No. 20101129)

Service: Trial Number:
118-12
Principal Investigator: Conducted at:
Long Beach Memorial, Orange Coast Memorial
Currently enrolling additional patients:
Yes

GOG 3001: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of AMG386 with Paclitaxel and Carboplatin as First-Line Treatment of Subjects with FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers (Protocol No. 20101129). AMG 386 is a first-in-class, investigational, anti-angiogenic drug that provides potent and selective inhibition of angiopoietins (formation of blood vessels from pre-existing blood vessels). This man-made medication was designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels (angiogenesis) to obtain a supply of oxygen and nutrients to grow. The purpose of this study is to see if treatment with paclitaxel and carboplatin (chemotherapy) plus AMG 386 followed by 18 months of AMG 386 continued after the chemotherapy will have an improved outcome compared to treatment with paclitaxel and carboplatin plus AMG 386 placebo followed by 18 months of AMG 386 placebo continued after the chemotherapy in the initial treatment of subjects with advanced epithelial ovarian, primary peritoneal or fallopian tube cancers.
Participants will participate in this study for about 8.5 years (102 months). This includes 18 weeks of treatment with chemotherapies (paclitaxel and carboplatin) and AMG 386 or AMG 386 placebo, 18 months of treatment with AMG 386 or AMG 386 placebo alone, and long-term follow-up visits/contacts (up to 72 months after the last subject is randomized in the study). All subjects will receive the chemotherapy, paclitaxel and carboplatin, every 3 weeks for up to 6 cycles (approximately 18 weeks). Subjects will be randomized to receive the investigational product, AMG 386 or AMG 386 placebo.

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