Phase 3 clinical trial to determine the treatment of drugs AMG 386 + Paclitaxel is better than paclitaxel + placebo in women with recurrent ovarian cancer.
- Conditions
- Health Condition 1: null- Fallopian Tube CancerOvarian CancerPrimary Peritoneal CancerHealth Condition 2: C569- Malignant neoplasm of unspecifiedovary
- Registration Number
- CTRI/2011/11/002163
- Lead Sponsor
- Amgen Technology Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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:
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-Free SurvivalTimepoint: Time Frame: 8 Months on average [ Designated as safety issue: No ] <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method