TRINOVA-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer

Stopped early · Phase 3 · Has a placebo group

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

In brief

The purpose of this study is to determine whether AMG 386 or AMG 386 Placebo in combination with Paclitaxel and Carboplatin are effective in the treatment of ovarian cancer.

Key facts

Study ID

NCT01493505

Run by

Amgen

People needed

1015

Starts

2012-01-01

Expected to finish

2016-12-01

Last updated by the study team

2017-02-23

Who can join

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

You may qualify if…

• Female subjects 18 years of age or older with FIGO Stages III-IV epithelial ovarian, primary peritoneal or fallopian tube cancer with an indication for first-line treatment with paclitaxel and carboplatin x 6 cycles (Subjects with pseudomyxoma, mesothelioma, adenocarcinoma with an unknown primary tumour, carcinosarcoma, sarcoma, mucinous or neuroendocrine histology are excluded
• Subjects with FIGO Stage IIIA or IIIB disease must have undergone PDS for ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization
• Subjects with FIGO Stage IIIC or IV disease must either:
• Undergo PDS for epithelial ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization or
• Plan to have IDS following 3 cycles of paclitaxel and carboplatin plus AMG 386 or AMG 386 placebo for biopsy proven epithelial ovarian, primary peritoneal or fallopian tube cancer
• ECOG performance status of 0 or 1
• Adequate bone marrow, renal and hepatic function

You may not qualify if…

• Prior use of any anticancer therapy or experimental therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer
• Previous abdominal and/or pelvic external beam radiotherapy
• History of central nervous metastasis
• History of arterial or venous thromboembolism within 12 months prior to randomization
• Clinically significant cardiovascular disease within 12 months prior to randomization

Where it is running

• Research Site — Mobile, Alabama, United States
• Research Site — Anchorage, Alaska, United States
• Research Site — Gilbert, Arizona, United States
• Research Site — Peoria, Arizona, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Berkeley, California, United States
• Research Site — Burbank, California, United States
• Research Site — Concord, California, United States
• Research Site — Corona, California, United States
• Research Site — La Jolla, California, United States
• Research Site — Long Beach, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Orange, California, United States
• Research Site — Oxnard, California, United States
• Research Site — Rancho Mirage, California, United States
• Research Site — Sacramento, California, United States
• Research Site — Sacramento, California, United States
• Research Site — San Diego, California, United States
• Research Site — Aurora, Colorado, United States
• Research Site — Englewood, Colorado, United States
• Research Site — Bridgeport, Connecticut, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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