None listed
Conditions
Interventions
Paclitaxel 80mg/m2 IV QW and Blinded AMG 386 15mg/kg IV QW
Group name:Group 2 Type of group
Paclitaxel 80mg/m2 IV QW and Blinded AMG 386 Placebo IV QW
Group 1 Type of group
Sponsors
AMGEN INC.,
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Female 18 years of age or older at the time the written informed consent is obtained • Gynecologic Oncology Group (GOG) Performance Status of 0 or 1 • Life expectancy >= 3 months (per investigator opinion) • Histologically or cytologically documented invasive epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (Subjects with pseudomyxoma , mesothelioma, unknown primary tumor, sarcoma, or neuroendocrine histology, with borderline ovarian cancer, ie, subjects with low malignant potential tumors, and with clear cell or mucinous histology are excluded) • Subjects must have undergone surgery for ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including at least a unilateral oophorectomy • Radiologically evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with modifications • Subjects must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. This initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation therapy, bevacizumab or extended therapy administered after surgical or non-surgical assessment. • Adequate organ and hematological function • Generally well controlled blood pressure with systolic blood pressure <= 140 mmHg and diastolic blood pressure <= 90 mmHg prior to randomization. The use of anti-hypertensive medications to control hypertension is permitted • Radiographically documented disease progression either on or following the last dose of prior chemotherapy regimen for epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
Exclusion criteria
Exclusion criteria: • Subjects who have received more than 3 previous regimens of anti-cancer therapy for epithelial ovarian, primary peritoneal or fallopian tube cancers • Subjects who have received paclitaxel as consolidation therapy, maintenance, or monotherapy are excluded • Subjects with primary platinum-refractory disease • Subjects with platinum-free interval (PFI) > 12 months from their last platinum based therapy • Radiotherapy = Grade 2 in severity except alopecia • Known active or ongoing infection (except uncomplicated urinary tract infection [UTI]) within 14 days prior to randomization • Currently or previously treated with AMG 386, or other molecules that inhibit the angiopoietins or Tie2 receptor • Treatment within 30 days prior to randomization with strong immune modulators including but not limited to systemic cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, methotrexate, azathioprine, rapamycin, thalidomide, and lenalidomide • Clinically significant cardiovascular disease within 12 months prior to randomization • Major surgery within 28 days prior to randomization or still recovering from prior surgery • Minor surgical procedures, except placement of tunneled central venous access device within 3 days prior to randomization. Diagnostic laparoscopy is regarded as a minor surgical procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:SLP is defined as the time from the date of randomization to the earliest date of the first objective progression of the disease, according to RECIST 1.1 with modifications, or death from any cause. Measure:Progression Free Survival (SLP) Timepoints:During the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Time from the date of randomization to the date of death. Subjects who have not died before the cut-off date of the data analysis will be ruled on the date of the last contact. Measure:Overall Survival (OS) Timepoints:During the study ; Outcome name:The objective response rate analysis will be carried out in the Measurable Disease in the set of baseline analyzes. An exact 2-sided binomial confidence interval of 95% will be generated for the objective response rate for each treatment arm. Measure:Objective Response Rate (ORR) Timepoints:During the study ; Outcome name:The DDR analysis will be carried out in the subset of subjects within the set of Measurable Disease at the baseline visit who experienced an objective response during the study. Measure:Response Duration (DDR) Timepoints:During the study ; Outcome name:The analysis of the response rate of CA-125 will be carried out in the set of evaluable analyzes for CA-125 and will be like the analysis of the objective response rate. Measure:CA-125 Response Rate Timepoints:During the study ; Outcome name:The analysis of the change in CA-125 (the maximum percentage change from the baseline visit) will be carried out within the RTD analysis set. Statistics summaries, 95% confidence intervals on 2 sides, and graphical summaries will be generated for the percentage change in CA-125 from the baseline visit for each treatment arm. Measure:Change in CA-125 Timepoints:During the study ; Outcome name:The analysis of the change in tumor burden (the maximum percentage change from the baseline visit in the sum of the longest diameters of the target lesions) will be carried out in the set of Measurable Disease analysis at the baseline visit. Measure:Change in Tumor Load Timepoints:During the study | — |
Countries
Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Czech Republic, Estonia, France, Greece, Hong Kong, India, Israel, Italy, Japan, Korea South, Latovia, Malasya, Mexico, Poland, Portugal, Romania, Russian Federation, Slovenia, South Africa, Spain, Sweden, Switzerland, United Kindgdom, United States
Contacts
Public ContactGabriela Celina Cajahuaringa
IQVIA RDS Peru S.R.L
Outcome results
None listed