Status:
TERMINATED
TRINOVA-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer
Lead Sponsor:
Amgen
Conditions:
Fallopian Tube Cancer
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
1015 Patients enrolled
Trial Details
Trial ID
NCT01493505
Start Date
January 1 2012
End Date
December 1 2016
Last Update
February 23 2017
Active Locations (310)
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1
Research Site
Birmingham, Alabama, United States, 35233
2
Research Site
Mobile, Alabama, United States, 36604
3
Research Site
Anchorage, Alaska, United States, 99508
4
Research Site
Gilbert, Arizona, United States, 85234