NCT00073125已完成2 期
A Phase II Randomized Study Evaluating the Safety and Efficacy of ABT-510 in Subjects With Advanced Renal Cell Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 103
- 试验地点
- 33
- 主要终点
- Progression free survival
研究概览
简要总结
The primary objective of this study is to assess the safety and efficacy of ABT-510 in subjects with advanced renal cell carcinoma.
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
- Single
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
- •A subject will be eligible for study participation if all of the following criteria are met:
- •The subject is at least 18 years of age.
- •The subject has advanced histologically documented renal cell carcinoma. Advanced disease is defined as locally recurrent disease or metastatic disease that is not amendable to curative resection.
- •The subject has not received prior therapy (anti-tumor radiotherapy, immunotherapy, chemotherapy, or investigational therapy) for metastatic renal cell carcinoma other than excision of primary tumor where appropriate. Local radiation for supportive reasons will be allowed; however, not within 28 days from Study Day
- •The subject has an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1
- •The subject is able to self-administer or has a caregiver who can reliably administer subcutaneous injections.
- •The subject must have adequate bone marrow, renal, and hepatic function as follows:
- •Bone Marrow: White blood cell count (WBC) ≥ 3,000/mm3 (3.0 X 109/L); Platelets ≥ 100,000/mm3 (100 X 109/L); Hemoglobin ≥ 9.0 g/dL (1.4 mmol/L)
- •Renal function: serum creatinine ≤ 2.0 mg/dL (0.81 mmol/L)
- •Hepatic function: AST and ALT ≤ 1.5 X ULN unless liver metastases are present, then AST and ALT ≤ 5.0 X ULN; LDH ≤ 1.5 X ULN; bilirubin ≤ 1.5 mg/dL (0.026 mmol/L) Corrected calculated calcium ≤ 10 mg/dL (2.5 mmol/L) Calculation = total calcium - 0.707 (albumin -3.4)Albumin ≥ 3.0 g/dL (0.45 mmol/L)
- •The subject must not be pregnant or lactating and all subjects (male and female) must use a contraceptive method deemed acceptable by the investigator while in the study and for up to two months following completion of therapy.
- •The subject has voluntarily signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved consent prior to any study specific procedures.
排除标准
- •A subject will be ineligible for study participation if any of the following criteria are met:
- •The subject has a history of or currently exhibits Central Nervous System (CNS) metastasis. Brain MRI within 28 days of enrollment is required to confirm absence of CNS metastases.
- •The subject is receiving therapeutic anticoagulation therapy. Low dose anticoagulation (e.g., low dose Coumadin) for catheter prophylaxis will be permitted; PT/PTT must be within normal limits.
- •The subject has a history of or currently exhibits clinically significant cancer related events of bleeding (e.g., hemoptysis). The subject has a recent history of (within 4 weeks of Study Day 1) or currently exhibits other clinically significant signs of bleeding.
- •The subject exhibits evidence of clinically significant uncontrolled conditions(s) and/or is considered by the investigator to be unable to tolerate the proposed treatment or procedures.
- •The subject has history of other previous malignancies within 5 years, with the exception of: Adequately treated in situ carcinoma of the cervix uteri or Basal or squamous cell carcinoma of the skin
结局指标
主要结局
Progression free survival
时间窗: One year
次要结局
- Performance status(One year)
- Overall survival(One year)
- Response rate(One year)
研究者
研究点 (33)
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