A Multi-Centre, Open Label, Phase II Study of the Safety, Efficacy and Pharmacokinetic (PK) Profile of CAP-232 Administered Through Continuous Intravenous Infusion in Patients With Metastatic Kidney Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- The primary efficacy parameter was the response rate based on RECIST criteria after 3 cycles
研究概览
简要总结
The purpose of this study was to evaluate the safety and efficacy of CAP-232 in the treatment of patients with previously treated (refractory) renal cell carcinoma
详细描述
This was a multi-center, open label, single arm study. Approximately 40 patients were initially planned to be recruited.
Each patient was to receive a treatment cycle consisting of CAP-232 via continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period. Treatment cycles to be repeated in the absence of disease progression or unacceptable toxicity.
Quality of Life questionnaires were to be administered at baseline, after each visit and at the end of the study.
Signs and symptoms of adverse events were closely monitored during treatment cycles. Safety laboratory measures were done at Screening, during the 72hr hospitalization (first cycle), at every interim visit , and at the end of the study. A follow-up safety visit was to be scheduled at least 30 days after the end of treatment.
CAP-232 plasma levels were also determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed stage IV kidney clear cell carcinoma.
- •Confirmed progressive disease after receiving a previous systemic therapy, including at least one line of standard of care.
- •Measurable disease
- •Age >18 years.
- •Life expectancy of greater than 3 months.
- •At least 5 years free of any other cancer(s). Basal cell carcinoma, provided that is neither infiltrating nor sclerosing and carcinoma in situ of the cervix, is acceptable.
- •ECOG performance status 2 or lower (Karnofsky 60%).
- •Normal organ and marrow function
- •Adequate contraception prior to study entry and for the duration of study participation.
- •Ability to understand and have the willingness to sign a written informed consent document.
- •Ability to receive central vein access catheter and manage an infusion pump.
- •Women of child bearing potential must have a negative serum pregnancy test.
排除标准
- •Anti-cancer therapy within 4 weeks prior to entering the study
- •Investigational agents less than 30 days prior to enrollment in the study.
- •Known brain metastases
- •History of allergic reactions attributed to compounds of similar composition to CAP-
- •Past or current cancer other than kidney cancer, except for: Curatively treated non-melanoma skin cancer, In situ carcinoma of the cervix, Other cancer curatively treated and with no evidence of disease for at least 5 years
- •Uncontrolled intercurrent illness /social situations that would limit compliance with study requirements.
- •Breastfeeding
- •Patients previously enrolled into this study and subsequently withdrawn
研究组 & 干预措施
CAP-232
Continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period.
干预措施: CAP-232 (Drug)
结局指标
主要结局
The primary efficacy parameter was the response rate based on RECIST criteria after 3 cycles
次要结局
- Quality of life
- Safety (through clinical and biological evaluations)
- Other efficacy parameters (progression-free survival rate, time to progression and overall survival)
- Pharmacokinetic (PK) characteristics of the first 15 recruited patients
- Biological modulation (through potential blood and/or urine biomarkers including M2PK)