NCT04729608终止3 期
A Phase 3, Randomized, Double-Blind, Placebo/Paclitaxel-Controlled Study of Batiraxcept (AVB-S6-500) in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer (AXLerate-OC)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 366
- 试验地点
- 149
- 主要终点
- Anti-tumor activity of batiraxcept in combination with PAC measured by progression free survival (PFS) in patients receiving batiraxcept + PAC versus patients receiving Placebo+PAC
研究概览
简要总结
This is a randomized, double-blind Phase 3 study to compare the efficacy and safety of batiraxcept (AVB-S6-500) in combination with paclitaxel (PAC) versus placebo in combination with PAC in patients with platinum resistant recurrent ovarian cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed and documented recurrent ovarian, fallopian tube, or peritoneal cancer. Only patients with high-grade serous adenocarcinoma histology are eligible.
- •Aged 18 years or older
- •Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1
- •Platinum-resistant disease (defined as progression within ≤6 months from completion of most recent platinum-containing regimen and calculated from the date of the last administered dose of platinum therapy).Subject may have been treated with additional regimen(s) subsequent to determination of platinum resistance.
- •Available archived tumor tissue or if archived tissue is not available, a fresh tumor biopsy.
- •Received at least 1 but not more than 4 prior therapy regimens.
- •Note: Maintenance therapy OR hormonal therapies should not be counted as a separate therapy.
- •Note: Patients who have not received prior bevacizumab must be deemed medically inappropriate OR ineligible to receive bevacizumab, refused to receive bevacizumab, or been unable to receive bevacizumab due to lack of access.
- •Measurable disease according to RECIST v1.1 criteria
- •Normal gastrointestinal function.
- •At least 28 days between termination of prior anticancer or hormonal therapy and first administration of batiraxcept.
- •Full recovery from all treatment-related toxicities to Grade 1 or less, except alopecia.
排除标准
- •Tumors in the breast or bone
- •Untreated central nervous system (CNS) metastases. Subjects requiring corticosteroid therapy for the management of their treated CNS metastases may not be on >10 mg/day prednisone or equivalent or have demonstrated signs or symptoms of neurologic instability for 28 days or less prior to randomization.
- •Primary platinum-refractory disease (defined as progression during or within 4 weeks after completion of the first platinum regimen)
- •Is being treated with concurrent anticancer therapy or other interventional treatments administered for their underlying ovarian cancer.
- •Received prior therapy with PAC in the platinum-resistant recurrent setting
- •Evidence of clinically significant third spacing (e.g., pleural effusions, ascites, anasarca, etc.) that requires therapeutic intervention within 28 days prior to first dose of batiraxcept/placebo
研究组 & 干预措施
Batiraxcept+PAC
Experimental
Combination of batiraxcept and PAC
干预措施: Batiraxcept (Drug)
Batiraxcept+PAC
Experimental
Combination of batiraxcept and PAC
干预措施: Paclitaxel (Drug)
Placebo+PAC
Placebo Comparator
Placebo-controlled arm with PAC
干预措施: Paclitaxel (Drug)
Placebo+PAC
Placebo Comparator
Placebo-controlled arm with PAC
干预措施: Placebo (Other)
结局指标
主要结局
Anti-tumor activity of batiraxcept in combination with PAC measured by progression free survival (PFS) in patients receiving batiraxcept + PAC versus patients receiving Placebo+PAC
时间窗: 4 months
PFS is the time interval between randomization and radiologically documented disease progression or death, whichever comes first.
次要结局
- Overall survival(20 months)
研究者
研究点 (149)
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