A Phase 1b, Parallel Arm, Multicenter, Open-Label Study of the Safety and Pharmacokinetics of AGS-8M4 Given in Combination With Two Different Chemotherapy Regimens in Women With Platinum Resistant or Platinum Sensitive Ovarian Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This is a parallel arm study to evaluate AGS-8M4 administered in combination with chemotherapy in subjects with ovarian cancer. AGS-8M4 will be administered as an IV infusion until disease worsens.
详细描述
All Subjects will receive AGS-8M4 treatment. Subjects will be enrolled into 1 of 2 treatment arms according to their disease status. A disease assessment will be performed every 8 or 9 weeks (± 3 days) depending on the treatment arm assignment. The assessment will be based both on changes in clinical symptoms, and radiographic images. Subjects without evidence of disease progression may continue to receive treatment based on their original treatment assignment until disease progression or intolerability. A safety follow-up visit will occur 4 weeks after the last dose infusion of AGS-8M4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects with recurrent disease Stage III/IV diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma
- •Subjects with either platinum resistant or platinum sensitive ovarian cancer
- •At least 14 days of previous cytotoxic chemotherapy and have recovered from all toxicities
- •Left ventricular ejection fraction (LVEF) equal to or greater than the institutional lower limit of normal as measured by echocardiogram or MUGA (ONLY required for platinum resistant patients)
排除标准
- •Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) within 72 hours of screening
- •Use of any investigational drug within 30 days prior to screening
- •Prior monoclonal antibody therapy other than Avastin
- •Avastin administration within 90 days of screening
- •History of thromboembolic events and bleeding disorders ≤ 3 months (e.g.,DVT or PE)
研究组 & 干预措施
A. PLD plus AGS-8M4
Women with platinum resistent ovarian cancer
干预措施: AGS-8M4 (Biological)
A. PLD plus AGS-8M4
Women with platinum resistent ovarian cancer
干预措施: Pegylated liposomal doxorubicin (PLD) (Drug)
B. Carboplatin and gemcitabine plus AGS-8M4
Women with platinum sensitive ovarian cancer
干预措施: AGS-8M4 (Biological)
B. Carboplatin and gemcitabine plus AGS-8M4
Women with platinum sensitive ovarian cancer
干预措施: gemcitabine (Drug)
B. Carboplatin and gemcitabine plus AGS-8M4
Women with platinum sensitive ovarian cancer
干预措施: carboplatin (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: Throughout the treatment
次要结局
- Assessment of PK variables(Treatment Arm A: Weeks 1 and 3 of each cycle. Treatment Arm B: Week 1 of each cycle. In addition, samples will be drawn at the Safety F/U, 2 Month F/U and 3 Month F/U visits.)
- Incidence of anti-AGS-8M4 antibody formation(Treatment Arm A: Day 1 of every other cycle and at Day 15 for the first cycle only. Treatment Arm B: Day 1 of every other cycle. In addition, samples will be drawn at the Safety F/U, 2 Month F/U and 3 Month F/U visits.)
- Changes in tumor status per RECIST(Treatment Arm A: Every 8 weeks. Treatment Arm B: Every 9 weeks.)
- Change in CA-125 levels(Treatment Arm A: Day 1 and Day 15 of each cycle. Treatment Arm B: Day 1 of each cycle. In addition, samples will be drawn at the Safety F/U.)