Brief Title
TRINOVA-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer
Official Title
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
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Progression free survival
Secondary Outcome
Overall survival (OS)
Condition
Fallopian Tube Cancer
Intervention
AMG 386
Study Arms / Comparison Groups
Placebo
Description: Placebo Paclitaxel Carboplatin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
1015
Start Date
January 2012
Completion Date
December 2016
Primary Completion Date
March 2016
Eligibility Criteria
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
MD, ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT01493505
Organization ID
20101129
Secondary IDs
TRINOVA-3 20101129/ENGOT-ov2
Responsible Party
Sponsor
Study Sponsor
Amgen
Study Sponsor
MD, Study Director, Amgen
Verification Date
February 2017