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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
919
Weekly Intravenous (IV) AMG 386 15 mg/kg
Weekly Intravenous (IV) placebo 15 mg/kg
Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off)
Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off)
Research Site
Phoenix, Arizona, United States
Research Site
Los Angeles, California, United States
Research Site
San Diego, California, United States
Research Site
Stanford, California, United States
Research Site
Englewood, Colorado, United States
Research Site
Progression-Free Survival
Time frame: 8 Months on average
Overall survival
Time frame: 20 months on average
Objective Response Rate
Time frame: From Baseline (if subject has Measurable Disease) until objective response (radiologic)
Duration of response
Time frame: From Baseline until progression
CA-125 response rate per Gynecologic Cancer Intergroup (GCIG) and change in CA-125
Time frame: From Baseline until CA-125 response
Incidence of adverse events and significant laboratory abnormalities
Time frame: 8 Months on average
Pharmacokinetics of AMG 386 (Cmax and Cmin)
Time frame: Week 1 until week 9 of treatment
Incidence of the occurrence of anti-AMG 386 antibody formation
Time frame: 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)
Time frame: From week 1 until 30-days following last study drug administration
Overall health status using EuroQOL(EQ-5D)
Time frame: From week 1 until 30-days following last study drug administration
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Danbury, Connecticut, United States
Research Site
New Haven, Connecticut, United States
Research Site
Hollywood, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Honolulu, Hawaii, United States
...and 215 more locations