NCT00352677已完成1 期
A Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of INNO-406 in Adult Patients With Imatinib-Resistant or Intolerant Philadelphia Chromosome-Positive (Ph+) Leukemias
CytRx12 个研究点 分布在 3 个国家目标入组 100 人开始时间: 2006年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 12
- 主要终点
- To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of INNO-406 when administered as a single agent to adult patients with imatinib-resistant or intolerant Ph+ leukemias.
研究概览
简要总结
The purpose of this study is to determine the safety and effectiveness of INNO-406 in adult patients with imatinib-resistant or intolerant Philadelphia chromosome-positive (Ph+) leukemias.
详细描述
The purpose of this study is to determine the safety, tolerability and pharmacokinetic profile of INNO-406 when administered as a daily oral agent in adult patients with imatinib-resistant or intolerant Philadelphia chromosome-positive (Ph+) leukemias.
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
- •Have a confirmed diagnosis of Ph+ ALL or CML in chronic, accelerated, or blastic phases that are either resistant to or intolerant of imatinib therapy.
- •Be ≥18 years old.
- •Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤
- •Have an estimated life expectancy of ≥12 weeks.
- •Be male or non-pregnant, non-lactating female. Patients who are fertile must agree to use an effective barrier method of contraception while on therapy and for 90 days following discontinuation of study drug.
- •Have a negative serum or urine pregnancy test within 7 days prior to the first dose of study drug (if patient is a female of childbearing potential).
- •Have acceptable pre-treatment clinical laboratory results.
排除标准
- •Have received chemotherapy ≤1 week from the start of therapy, with the exception of hydroxyurea and corticosteroids.
- •Have received imatinib ≤3 days prior to enrollment or have not recovered from side effects of imatinib therapy.
- •Have impaired cardiac function.
- •Have an active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment.
- •Have clinically significant acute or chronic liver or renal disease considered unrelated to tumor.
- •Have impaired gastrointestinal function that may significantly alter drug absorption (e.g., uncontrolled vomiting, ulcerative colitis, malabsorption, or small bowel resection).
- •Are pregnant or lactating.
- •Have psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
- •Have not recovered from acute toxicity of all previous therapy prior to enrollment.
- •Have any other severe concurrent disease and/or uncontrolled medical conditions, which, in the judgment of the investigator, could predispose patients to unacceptable safety risks or compromise compliance with the protocol.
- •Have a history of another primary malignancy that is currently clinically significant or requires active intervention.
结局指标
主要结局
To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of INNO-406 when administered as a single agent to adult patients with imatinib-resistant or intolerant Ph+ leukemias.
时间窗: One year
To determine the safety profile (including acute and chronic toxicities) and tolerability of INNO-406 in this patient population.
时间窗: One year
次要结局
- To determine the pharmacokinetic (PK) profile of INNO-406.(One year)
- To assess BCR-ABL transcript levels and to analyze BCR-ABL mutations.(One year)
- To assess leukemia response rates in this patient population.(One year)
研究者
研究点 (12)
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