NCT00431340终止2 期
A Phase II Study of Belinostat in Combination With Bortezomib in Patients 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
- Safety of belinostat plus bortezomib.
研究概览
简要总结
This open-label study will assess anti-tumor activity and safety of belinostat in combination with bortezomib (Velcade®) in multiple myeloma patients refractory to or relapsed from at least one prior bortezomib-containing regimen. Subjects will be administered both PXD101 and bortezomib on the same days: i.e. days 1, 4, 8, and 11 of a 3-week cycle, for up to 8 cycles.
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 multiple myeloma.
- •Status of refractory to or relapsed from at least one prior bortezomib-containing regimen.
- •Progressive disease.
- •Age >= 18 years.
- •Karnofsky performance status >= 60%
- •Acceptable liver function:
- •Bilirubin =< 1.5 x ULN (upper limit of normal)
- •Aspartate transaminase (AST) and alanine transaminase (ALT) =< 3 x ULN
- •Acceptable hematologic status:
- •Absolute Neutrophil Count (ANC) >= 1.5 x 109/L
- •Platelet count >= 100 x 109/L
- •Hemoglobin >= 9 g/dL
- •Coagulation status PT-INR/PTT =< 1.5 x ULN or in the therapeutic range if on anticoagulation therapy. (PT-INR/PTT= prothrombin - international normalized ratio / prothrombin time)
- •Serum potassium within normal range.
- •Estimated life expectancy greater than 3 months.
- •Signed, written IRB (institutional Review Board)-approved informed consent.
排除标准
- •Non-secretory multiple myeloma or symptomatic amyloidosis.
- •Hypersensitivity to bortezomib, boron, or mannitol.
- •Less than 4 weeks since prior chemotherapy, radiotherapy, endocrine therapy, or immunotherapy, except if disease is rapidly progressing.
- •Less than 4 weeks since prior use of other investigational agents.
- •Serious concomitant systemic disorders (e.g. active infection).
- •Significant cardiovascular disease.
- •Marked baseline prolongation of QT/QTc (corrected QT interval)interval.
- •Central nervous system disorders requiring neuroleptics / anti-convulsants.
- •Peripheral sensory neuropathy of ≥ Grade 2
- •Renal insufficiency defined as a creatinine clearance of < 30 ml/min.
- •Non-willingness to use effective contraceptive methods for patients of child-bearing age / potential.
- •Pregnant or breast-feeding women.
- •Known HIV positivity.
- •Prior treatment with belinostat (PXD101), or any other HDAC (histone deacetylase) inhibitor.
- •Altered mental status which precludes an understanding of the Informed Consent Document.
结局指标
主要结局
Safety of belinostat plus bortezomib.
Objective response rate of belinostat administered in combination with bortezomib in multiple myeloma subjects who are refractory to or have relapsed from at least one prior bortezomib-containing regimen.
次要结局
- Duration of response, time to response (TTR), and time to progression (TTP).
- Effect on biomarkers of bone metabolism. Effect on disease-related bone pain.
研究者
研究点 (6)
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