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



Status:Terminated
Conditions:Ovarian Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/24/2017
Start Date:January 2012
End Date:December 2016

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A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers

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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
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