Health Condition 1: null- Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cancer Health Condition 2: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: AMG 386: Drug: AMG 386
Weekly Intravenous (IV) AMG 386 15 mg/kg plus IV paclitaxel 80 mg/m2 weekly (3 on / 1 off) - Treament duration - approximatly 05 years
Control Intervention1: Pla
Sponsors
Amgen Technology Pvt Ltd
Eligibility
Inclusion criteria
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 (there must be radiographically visible tumor. Subjects with only ascites or pleural effusion are excluded) 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
Exclusion criteria
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 with primary platinum-refractory disease Subjects with platinum-free interval (PFI) 12 months from their last platinum based therapy Radiotherapy 14 days prior to randomization. Subjects must have recovered from all radiotherapy-related toxicities (If all sites of disease have been irradiated, documented progression must have occurred in at least 1 site of disease subsequent to the radiation therapy) Previous abdominal or pelvic radiotherapy History of arterial or venous thromboembolism within 12 months prior to randomization History of clinically significant bleeding within 6 months prior to randomization History of central nervous system metastasis Clinically significant cardiac disease within 12 months prior to randomization Uncontrolled hypertension Major surgery within 28 days prior to randomization or still recovering from prior surgery Minor surgical procedures, including placement of tunneled central venous access device within 3 days prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free SurvivalTimepoint: Time Frame: 8 Months on average [ Designated as safety issue: No ] | — |
Secondary
| Measure | Time frame |
|---|---|
| CA-125 response rate per Gynecologic Cancer Intergroup (GCIG) and change in CA-125Timepoint: [ Time Frame: From Baseline until CA-125 response ] [ Designated as safety issue: No ] ;Duration of responseTimepoint: [ Time Frame: From Baseline until progression ] [ Designated as safety issue: No ] ;Incidence of adverse events and significant laboratory abnormalitiesTimepoint: [ Time Frame: 8 Months on average ] [ Designated as safety issue: Yes ] ;Incidence of the occurrence of anti-AMG 386 antibody formationTimepoint: [ Time Frame: Week 1 until maximum of 1-year following last dose of study drug ] [ Designated as safety issue: Yes ] ;Objective Response RateTimepoint: [ Time Frame: From Baseline (if subject has Measurable Disease) until objective response (radiologic) ] [ Designated as safety issue: No ] ;Overall health status using EuroQOL(EQ-5D)Timepoint: [ Time Frame: From week 1 until 30-days following last study drug administration ] [ Designated as safety issue: No ] ;Overall survivalTimepoint: Time Frame: 20 months on average[ Designated as safety issue: No ];Patient reported Health Related Quality of Life (HRQOL) and ovarian cancer related symptoms using Functional Assessment of Cancer Therapy - Ovary questionnaire (FACT-O)Timepoint: [ Time Frame: From week 1 until 30-days following last study drug administration ] [ Designated as safety issue: No ];Pharmacokinetics of AMG 386 (Cmax and Cmin)Timepoint: [ Time Frame: Week 1 until week 9 of treatment ] [ Designated as safety issue: No ] | — |
Countries
Australia, Brazil, Canada, Chile, Croatia, Czech Republic, Estonia, France, Greece, India, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Norway, Peru, Poland, Portugal, Romania, Russian Federation, Slovenia, South Africa, Spain, Sweden, Switzerland, United States of America
Contacts
Public ContactDr Veena Jaguste
Amgen Technology Pvt. Ltd
Outcome results
None listed