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 2nd Ovarian cancer Global Phase 3 clinical trial
version:
date:
Takeda Pharmaceutical Company Limited
https://www.takeda.co.jp/contact/form/jp/form/
900
Interventional
Randomized, Double-Blinded, Placebo-controlled
3
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
18age old over
No limit
Female
Recurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancers
investigational material(s)
Generic name etc : AMG 386
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Intravenous
control material(s)
Generic name etc : Placebo
INN of investigational material :
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Intravenous
