AMG 386 2nd Ovarian cancer Global Phase 3 clinical trial
- Conditions
- Recurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancers
- Registration Number
- JPRN-jRCT2080221277
- Lead Sponsor
- Takeda Pharmaceutical Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Female
- Target Recruitment
- 900
Major inclusion criteria include the following:
- 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
Major exclusion criteria include the following:
- 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
- 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 PFS<br>Intergroup trial
- Secondary Outcome Measures
Name Time Method OS<br>Intergroup trial