Phase I/II BNC105P Combination Study in Partially Platinum Sensitive Ovarian Cancer Patients in First or Second Relapse
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 6
- 主要终点
- Phase I: Determine Maximum Tolerated Dose for Patients
研究概览
简要总结
This phase I/II trial will determine the recommended dose and activity of BNC105P for patients with partially platinum sensitive ovarian cancer in first or second relapse.
详细描述
OUTLINE: This is a multi-center study.
BNC105P is a novel vascular disrupting agent (VDA) with promising preclinical activity combined with platinum or gemcitabine. The results of standard chemotherapy with carboplatin and gemcitabine for ovarian cancer relapsing within 12 months of an initial platinum-based regimen require improvement. This trial will determine the recommended dose and activity of BNC105P administered with carboplatin and gemcitabine.
PHASE I:
This trial uses a standard 3+3 design for allocating participants to a starting dose level in Phase I.
If dose level 1 is deemed to have acceptable toxicity then dose levels 2a and 2b can be opened at the same time. Dose level 3 will only open if both dose levels 2a and 2b are deemed to have acceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Phase II Arm A
Phase II Arm A will randomize patients to treatment regimen of carboplatin and gemcitabine without BNC105P
干预措施: Carboplatin (Drug)
Phase II Arm A
Phase II Arm A will randomize patients to treatment regimen of carboplatin and gemcitabine without BNC105P
干预措施: Gemcitabine (Drug)
Phase II Arm B
Phase II Arm B will randomize patients to treatment regimen of carboplatin and gemcitabine and will include BNC105P
干预措施: Carboplatin (Drug)
Phase II Arm B
Phase II Arm B will randomize patients to treatment regimen of carboplatin and gemcitabine and will include BNC105P
干预措施: Gemcitabine (Drug)
Phase II Arm B
Phase II Arm B will randomize patients to treatment regimen of carboplatin and gemcitabine and will include BNC105P
干预措施: BNC105P (Drug)
结局指标
主要结局
Phase I: Determine Maximum Tolerated Dose for Patients
时间窗: 12 months
To determine the recommended dose of BNC105P given with gemcitabine and carboplatin (maximum dose of BNC105P with no more than 1 DLT in 6 phase I participants)
Phase II: Determine Objective Response Rate in Patients
时间窗: 12 months
To determine the objective response rate (ORR) in those with evaluable disease (ORR = CR, PR according to RECIST 1.1 and/or GCIG CA125 criteria) (percentage of those with measurable disease achieving CR or PR according to RECIST 1.1 and/or GCIG CA125 criteria)
次要结局
- Patient Side Effects and Tolerability(12 months)
- Progression Free and Overall Survival Distribution(12 months)
- Patient Quality of Life Benefits(12 months)
- Assessment of BNC105P Pharmacokinetics to Determine Interaction with Carboplatin and Gemcitabine(12 months)
- Association of Biomarkers, Predictions and Outcomes(12 months)