Recurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancers
Conditions
Sponsors
Takeda Pharmaceutical Company Limited
Amgen Inc., U.S.A.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS Intergroup trial | — |
Secondary
| Measure | Time frame |
|---|---|
| OS Intergroup trial | — |
Outcome results
None listed