NCT00322673终止2 期
A Phase 2 Study of XL999 Administered Intravenously to Subjects With Acute Myeloid Leukemia
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 14
- 主要终点
- Hematologic and cytogenetic response rate
研究概览
简要总结
This clinical study is being conducted at multiple sites to determine the activity, safety and tolerability of XL999 when given weekly to patients with relapsed or newly-diagnosed AML. XL999 is a small molecule inhibitor against Flk1/kinase insert domain receptor (KDR), PDGFR, c-Kit, FLT3 and SRC. c-Kit and FLT3 are receptors commonly expressed on AML blasts.
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
- •Diagnosis of acute myeloid leukemia (except AML FAB-M3 or acute promyelocytic leukemia [APL]) based on the World Health Organization (WHO) classification of ≥ 20% blasts in the bone marrow or peripheral blood at initial diagnosis (prior to start of standard chemotherapy)
- •ECOG performance status of 0 or 1
- •Subjects with newly-diagnosed AML or subjects with relapsed AML after at least 2 chemotherapy regimens.
- •Adequate liver and renal function
- •Signed informed consent
排除标准
- •Anticancer therapy including chemotherapeutic, biologic, or investigative agents within 30 days of XL999 treatment
- •Hematopoietic stem cell transplantation within the previous 6 weeks
- •Immunosuppressive therapy (eg, cyclosporine, steroids, tacrolimus) for graft-versus-host disease (GvHD) within 30 days prior to the start of XL999
- •The subject has not recovered to grade ≤ 1 or to within 10% of baseline from adverse events due to investigational or chemotherapeutic drugs or stem cell transplantation which were administered > 4 weeks prior to study enrollment
- •Uncontrolled and/or concomitant illness
- •Pregnant or breastfeeding females
- •Known HIV
结局指标
主要结局
Hematologic and cytogenetic response rate
时间窗: Inclusion until disease progression
Safety and tolerability
时间窗: Inclusion until 30 dyas post last treatment
次要结局
- Duration of hematologic response and transfusion independence(Inclusion until disease progression)
- Progression-free survival(Inclusion until disease progression)
- Overall survival(Inclusion until 180-day Follow-up post last treatment or death)
研究者
研究点 (14)
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