AMG 386 (Trebananib) in Ovarian Cancer (TRINOVA-2)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cancer

In brief

To determine if AMG 386 plus pegylated liposomal doxorubicin (PLD) is superior to placebo plus PLD as measured by progression-free survival (PFS) The hypothesis for this study is that AMG 386 plus PLD will prolong PFS compared to placebo plus PLD in women with recurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancer.

Key facts

Study ID

NCT01281254

Run by

Amgen

People needed

223

Starts

2011-04-18

Expected to finish

2017-04-19

Last updated by the study team

2017-12-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically documented invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer
• Radiographically documented disease progression either on or following the last dose of the prior regimen for epithelial ovarian, primary peritoneal, or fallopian tube cancer
• Subjects must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound.
• Female 18 years of age or older at the time the written informed consent is obtained
• Adequate organ and hematological function

You may not qualify if…

• Subjects who have received more than 3 previous regimens of anti cancer therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer
• Subjects treated with prior pegylated liposomal doxorubicin (PLD) or any anthracycline-based or mitoxantrone-based chemotherapy
• Subjects with primary platinum-refractory disease
• Subjects with platinum-free interval (PFI) > 12 months from their last platinum based therapy
• History of central nervous system metastasis
• Major surgery within 28 days prior to randomization or still recovering from prior surgery

Where it is running

• Research Site — San Francisco, California, United States
• Research Site — Norwalk, Connecticut, United States
• Research Site — Stamford, Connecticut, United States
• Research Site — Orlando, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Evanston, Illinois, United States
• Research Site — Saint Louis Park, Minnesota, United States
• Research Site — New York, New York, United States
• Research Site — Asheville, North Carolina, United States
• Research Site — Durham, North Carolina, United States
• Research Site — Winston-Salem, North Carolina, United States
• Research Site — Bismarck, North Dakota, United States
• Research Site — Abington, Pennsylvania, United States
• Research Site — Sioux Falls, South Dakota, United States
• Research Site — Fort Sam Houston, Texas, United States
• Research Site — San Antonio, Texas, United States
• Research Site — Annandale, Virginia, United States
• Research Site — Green Bay, Wisconsin, United States
• Research Site — Milwaukee, Wisconsin, United States
• Research Site — West Allis, Wisconsin, United States
• Research Site — New Lambton Heights, New South Wales, Australia
• Research Site — Wahroonga, New South Wales, Australia
• Research Site — Auchenflower, Queensland, Australia
• Research Site — Greenslopes, Queensland, Australia
• Research Site — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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