A Randomized, Phase 2 Study to Assess the Safety and Efficacy of CRLX101 in Combination With Bevacizumab in Patients With Metastatic Renal Cell Carcinoma (RCC) Versus Standard of Care (SOC) (Investigator's Choice)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 43
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This study to evaluate treatment in patients with metastatic renal cell carcinoma (RCC) which has progressed through 2 to 3 prior lines of therapy, with the investigational drug CRLX101 in combination with bevacizumab compared to treatment with a standard of care therapy. The study will compare which treatment resulted in longer time before progression of the RCC. Patients will be treated and followed for progression of their disease on average for up to 6 months.
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
- 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
- •Must have histologically confirmed renal cell carcinoma of any pathologic subtype.
- •Must have unresectable metastatic disease, and have tumor(s) present that is (are) evaluable by the RECIST, v1.1; may have spinal-associated metastases but must have concluded dexamethasone therapy and be evaluated by the Investigator to have stable CNS disease.
- •Must have received 2 or 3 prior lines of conventional molecularly targeted therapy
- •Must have full recovery from any toxicities from prior therapy CTCAE Grade 1 or less with the exception of Grade 2 alopecia) prior to randomization.
- •ECOG performance status 0 or
- •Age 18 years and older.
- •Life expectancy of at least 3 months.
- •Must have normal organ and marrow function reported within 14 days prior to randomization
- •Ability to understand and willingness to sign a written informed consent document.
- •Able to comply with study visit schedule and assessments.
排除标准
- •Any conventional molecularly targeted therapy within 2 weeks or, chemotherapy or radiotherapy within 2 weeks (local) or 4 weeks (systemic) prior to entering the study.
- •Failure to recover to grade 1 or less all prior adverse events.
- •Any major surgery within 4 weeks of study randomization.
- •Any prior treatment with topoisomerase I therapy.
- •Prior treatment with any drugs or therapies that will be administered during the course of this trial including CRLX101, any topoisomerase 1 inhibitor, bevacizumab or the conventional molecularly targeted agent intended for use as standard of care treatment.
- •Patients receiving any other current investigational therapeutic agent.
- •Other active malignancies
- •Patients with brain metastasis treated or untreated, or other CNS disease
- •Any clinically significant cardiac disease defined as NYHA class III or IV.
- •Uncontrolled hypertension
- •Uncontrolled concurrent illness
- •History of non-healing wounds or ulcers.
- •Pregnancy, or inadequate contraception for men or women of childbearing age, or lactating / breast-feeding
- •Patients with known HIV or with solid organ transplant
研究组 & 干预措施
CRLX101 + bevacizumab
CRLX101 in combination with bevacizumab:
- CRLX101 15 mg/m^2 IV on days 1 and 15 of a 28-day cycle;
- bevacizumab 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
干预措施: CRLX101 (Drug)
CRLX101 + bevacizumab
CRLX101 in combination with bevacizumab:
- CRLX101 15 mg/m^2 IV on days 1 and 15 of a 28-day cycle;
- bevacizumab 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
干预措施: Bevacizumab (Drug)
Standard of Care
Standard of care treatment include one of the following agents to which the patient can have no prior exposure: sorafenib; everolimus; pazopanib; axitinib; bevacizumab; sunitinib, or other approved drug considered by the Medical Monitor to represent an acceptable standard of care therapy
干预措施: Standard of Care (Investigator Choice) (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: at least 6 months
To assess progression free survival (PFS) in patients with clear cell metastatic renal cell carcinoma (RCC) treated with CRLX101 in combination with bevacizumab (CRLX101+bevacizumab) vs. standard of care (SOC) per investigator's choice, as assessed by blinded independent radiological review (IRR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
次要结局
- Overall survival(on average 12 months after discontinuation of study treatment)
- Overall Safety and tolerability (AEs, SAEs, Clinical Laboratory Parameters, Vital Signs, Concomitant Medications)(at least 30 days post last dose of study drug)
- Duration of Response(at least 6 months)
- Objective response rate(at least 6 months)
- PFS(at least 6 months)