NCT01584830已完成3 期
A Randomized, Double-blind, Placebo-controlled Phase III Study of Regorafenib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Asian Subjects With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 204
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of this study is to assess if Regorafenib in combination with best supportive care will slow down tumor progression and result in increased survival in patients with metastatic colorectal 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
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
- •Subjects with metastatic colorectal cancer(CRC) (Stage IV).
- •Subjects must have failed at least two lines of prior treatment.
- •Progression during or within 3 months following the last administration of approved standard therapies which must include a fluoropyrimidine, oxaliplatin and irinotecan.
- •Subjects treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy.
- •Subjects who progress more than 6 months after completion of oxaliplatin containing adjuvant treatment must be retreated with oxaliplatin-based therapy to be eligible.
- •Subjects who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to progression of disease will also be allowed into the study.
- •Subjects may have received prior treatment with Avastin (bevacizumab) and/or Erbitux (cetuximab)/Vectibix (panitumumab) (if KRAS WT)
- •Metastatic CRC subjects must have measurable or non measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of
- •Life expectancy of at least 3 months.
- •Adequate bone marrow, liver and renal function as assessed by the laboratory required by protocol.
排除标准
- •Prior treatment with Regorafenib.
- •Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)].
- •Extended field radiotherapy within 4 weeks or limited field radiotherapy within 2 weeks prior to randomization.
- •Cardiological disease including Congestive heart failure, Unstable angina, Myocardial infarction, Cardiac arrhythmias requiring anti-arrhythmic therapy.
- •Uncontrolled hypertension. (Systolic blood pressure 150 mmHg or diastolic pressure 90 mmHg despite optimal medical management).
- •Subjects with phaeochromocytoma.
- •Pleural effusion or ascites that causes respiratory compromise.
- •Arterial or venous thrombotic or embolic events.
- •Any history of or currently known brain metastases.
- •Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
- •Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 4 week.
研究组 & 干预措施
Arm 1
Experimental
干预措施: Regorafenib (BAY73-4506) (Drug)
Arm 2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: From randomization of the first subject untill 154 death events observed, up to 2 years
OS is defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
次要结局
- Progression-free Survival (PFS)(From randomization of the first subject untill 154 death events observed, up to 2 years)
- The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR).(From randomization of the first subject untill 154 death events observed, up to 2 years)
- Disease Control Rate (DCR)(From randomization of the first subject untill 154 death events observed, up to 2 years)
- Safety variables will be summarized using descriptive statistics based on adverse events collection(From randomization of the first subject untill 154 death events observed, up to 2 years)
研究者
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