NCT01204749

TRINOVA-1: A Study of AMG 386 or Placebo, in Combination With Weekly Paclitaxel Chemotherapy, as Treatment for Ovarian Cancer, Primary Peritoneal Cancer and Fallopian Tube Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 919 (actual)
• Sponsor: Amgen · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if treatment with paclitaxel plus AMG 386 is superior to paclitaxel plus placebo in women with recurrent partially platinum sensitive or resistant epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer. AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.

Conditions

• Fallopian Tube Cancer
• Ovarian Cancer
• Primary Peritoneal Cancer

Interventions

Type	Name	Description
DRUG	AMG 386	Weekly Intravenous (IV) AMG 386 15 mg/kg
DRUG	AMG 386 Placebo	Weekly Intravenous (IV) placebo 15 mg/kg
DRUG	Paclitaxel	Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off)
DRUG	Paclitaxel	Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off)

Timeline

• Start date: 2010-11-01
• Primary completion: 2013-03-01
• Completion: 2016-12-01
• First posted: 2010-09-17
• Last updated: 2016-12-15

Locations

225 sites across 32 countries: United States, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Czechia, Estonia, France, Greece, Hong Kong, India, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Peru, Poland, Portugal, Romania, Russia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, United Kingdom