A Phase 3, Randomized, Double-Blind Trial of Weekly Paclitaxel Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers - AMG 386 20090508
- Conditions
- MedDRA version: 9.1Level: LLTClassification code 10066697Recurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancers
- Registration Number
- EUCTR2010-019821-32-IT
- Lead Sponsor
- Amgen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 900
• Female of age 18 years or older • 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 are excluded - Subjects with borderline ovarian cancer, ie, subjects with low malignant potential tumors are excluded - Subjects with clear cell or mucinous histology are excluded • Subjects must have undergone surgery for ovarian cancer, primary peritoneal or fallopian tube cancer including at least a unilateral oophorectomy • 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 • Radiologically evaluable disease per 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. - Subjects are allowed to receive, but are not required to receive, two additional cytotoxic regimens for management of recurrent or persistent disease. • GOG performance status 0 or 1 (see Appendix H) • Adequate hematologic, renal and hepatic function
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• Subjects who have received more than three 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 recurrence or progression during the first 6 cycles or < 6 months after the beginning of the first-line platinum-based chemotherapy are excluded • Subjects with platinum-free interval (PFI) > 12 months from their last platinum-based therapy • History of central nervous system metastasis • Clinically significant cardiac disease within 12 months prior to randomization • History of arterial or venous thromboembolism within 12 months prior to randomization • Uncontrolled hypertension as defined as diastolic blood pressure > 90 mmHg OR systolic blood pressure > 140 mmHg • Hypersensitivity to paclitaxel or drugs using the vehicle cremophor
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine if paclitaxel plus AMG 386 is superior to paclitaxel plus placebo as measured by progression-free survival (PFS);Secondary Objective: To determine if paclitaxel plus AMG 386 is superior to paclitaxel plus placebo as measured by overall survival (OS);Primary end point(s): Progression-Free Survival
- Secondary Outcome Measures
Name Time Method