Adjuvant Axitinib Treatment of Renal Cancer: A Randomized Double-blind Phase 3 Study of Adjuvant Axitinib vs. Placebo in Subjects at High Risk of Recurrent RCC
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 724
- 主要终点
- Disease Free Survival (DFS) as Assessed by Blinded Independent Review Committee (IRC)
研究概览
简要总结
The purpose of this trial is to determine if adjuvant therapy with axitinib will prevent or delay the recurrence of renal cell cancer after surgery to remove the primary tumor in high risk patients.
详细描述
This is a prospective, randomized, double blind placebo controlled Phase 3 trial of oral axitinib starting at 5 mg twice daily given 3 years vs. placebo.
Approximately 700 patients will be randomized in a 1:1 ratio between axitinib vs placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients must be treated by nephrectomy and patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
- •Patients must have no evidence of macroscopic residual disease or metastatic disease.
- •Male or female, age >=18 years (age >=20 years in Japan, Korea and Taiwan).
- •Patients must be diagnosed with one of the following based on American Joint Committee on Cancer (AJCC) TNM staging version 2010, Eastern Collaborative Oncology Group (ECOG) performance status (PS):
- •pT2, pN0 or pNx, M0 and ECOG PS 0-1
- •pT3, pN0 or pNx, M0 and ECOG PS 0-1
- •pT4, pN0 or pNx, M0 and ECOG PS 0-1
- •Any pT, pN1, M0 and ECOG PS 0-1
- •Patients must have histologically confirmed preponderant, defined as >50%, clear cell RCC.
- •Patients must not have received any previous systemic (includes chemotherapeutic, hormonal, or immunotherapeutic) treatment for RCC.
- •Patients must not have received any previous anti angiogenic treatment.
- •Patients must have adequate organ function.
- •Exclusion Criteria
- •Histologically undifferentiated carcinomas, sarcomas, collecting duct carcinoma, lymphoma, or patients with any metastatic renal sites.
- •National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 hemorrhage <4 weeks of date of randomization.
- •Diagnosis of any non-RCC malignancy within the 5 years from date of randomization, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that has been adequately treated with no evidence of recurrent disease for 12 months.
- •Any of the following within the 12 months prior to study drug administration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism.
- •Gastrointestinal abnormalities
排除标准
- 未提供
研究组 & 干预措施
Axitinib
干预措施: Axitinib (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Disease Free Survival (DFS) as Assessed by Blinded Independent Review Committee (IRC)
时间窗: From randomization date up to first date of recurrence or the occurrence of a secondary malignancy or death (up to 5 years)
DFS is defined as time interval from the date of randomization to first date of recurrence/relapse (distant or local recurrence of \[RCC\] or occurrence of a secondary malignancy {occurrence of a second primary cancer other than RCC} or death). For participants with no DFS event, DFS was censored at date of last scan prior to time of analyses. Participants alive who did not have post-baseline disease assessments, DFS was censored at randomization. Participants who received further anti-tumor therapy prior to recurrence or occurrence of a secondary malignancy or death, DFS was censored on date of last scan prior to taking anti-tumor medication. Participants who missed 2 or more consecutive tumor scans immediately followed by an event were censored at date of last objective tumor assessment prior to missing/not readable scan.
次要结局
- Overall Survival (OS)(From randomization date until death due to any cause (up to 5 years))
- Number of Participants With Treatment-Emergent Adverse Events (AE) and Serious Adverse Events (SAEs)(From Day 1 up to 28 days after last dose (maximum duration of 3 years))
- Number of Participants With Treatment-Emergent Treatment Related Adverse Events and Serious Adverse Events (SAEs)(From Day 1 up to 28 days after last dose (maximum duration of 3 years))
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) By Severity(From Day 1 up to 28 days after last dose (maximum duration of 3 years))
- Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology(From Day 1 up to 28 days after last dose (maximum duration of 3 years))
- Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry(From Day 1 up to 28 days after last dose (maximum duration of 3 years))
- Number of Participants With Laboratory Abnormalities: Thyroid Function(From Day 1 up to 28 days after last dose (maximum duration of 3 years))
- Number of Participants With Laboratory Abnormalities: Urinalysis(From Day 1 up to 28 days after last dose (maximum duration of 3 years))