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
Study Details
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.
Protocol Summary
Progression-Free Survival
Timeframe: 8 Months on average
Overall survival
Timeframe: 20 months on average
Objective Response Rate
Timeframe: From Baseline (if subject has Measurable Disease) until objective response (radiologic)
Duration of response
Timeframe: From Baseline until progression
CA-125 response rate per Gynecologic Cancer Intergroup (GCIG) and change in CA-125
Timeframe: From Baseline until CA-125 response
Incidence of adverse events and significant laboratory abnormalities
Timeframe: 8 Months on average
Pharmacokinetics of AMG 386 (Cmax and Cmin)
Timeframe: Week 1 until week 9 of treatment
Incidence of the occurrence of anti-AMG 386 antibody formation
Timeframe: Week 1 until maximum of 1-year following last dose of study drug
Patient reported Health Related Quality of Life (HRQOL) and ovarian cancer related symptoms using Functional Assessment of Cancer Therapy – Ovary questionnaire (FACT-O)
Timeframe: From week 1 until 30-days following last study drug administration
Overall health status using EuroQOL(EQ-5D)
Timeframe: From week 1 until 30-days following last study drug administration