NCT00304590终止2 期
A Phase 2 Study of XL999 in Subjects With Relapsed/Refractory Multiple Myeloma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 6
- 主要终点
- 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 refractory multiple myeloma. XL999 is a small molecule inhibitor of cellular factors including VEGFR, PDGFR, and FGFR that may be involved in multiple myeloma.
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
- •Males and females with a diagnosis of MM based on bone marrow aspirate and biopsy with ≥10% plasma cells (or biopsy of a tissue with monoclonal plasma cells), M protein level in the serum or urine, and evidence of end organ or tissue impairment (hypercalcemia, renal insufficiency, anemia, or lytic bone lesions), as defined by The International Myeloma Working Group Criteria (2003), at initial diagnosis (before initiation of chemotherapy)
- •Measurable disease defined as serum and/or urine M component by electrophoresis
- •Refractory to or relapsed after 2 prior treatment regimens (chemotherapy, biologic or hematopoietic stem cell transplantation)
- •Concurrent therapy with a bisphosphonate is acceptable
- •ECOG performance status of 0 or 1
- •Life expectancy ≥3 months
- •Adequate liver function
- •No other malignancies within 5 years
- •Signed informed consent
排除标准
- •Nonsecretory myeloma, monoclonal gammopathy of uncertain significance (MGUS), or smoldering myeloma
- •Anticancer therapy including chemotherapeutic, biologic, or investigational agents, including dexamethasone, within 30 days of XL999 treatment
- •Hematopoietic stem cell transplantation within the previous 6 weeks
- •Radiation to ≥33% of bone marrow within 30 days of XL999 treatment
- •Subject has not recovered to grade ≤1 or to within 10% of baseline from adverse events due to investigational or chemotherapeutic drugs that were administered >30 prior to study enrollment
- •Uncontrolled and/or intercurrent illness
- •Pregnant or breastfeeding females
- •Known HIV
结局指标
主要结局
Response rate
时间窗: Inclusion of subject until disease progression
Safety and tolerability
时间窗: Inclusion until 30 days post last treatment
次要结局
- Duration of response(Inclusion until disease progression)
- Progression-free survival(Inclusion until disease progression)
- Overall survival(Inclusion until 180-day Follow-up or death)
研究者
研究点 (6)
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