NCT00918450撤回2 期
A Phase 2b Monotherapy Study of ABT-263 in Subjects With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Abbott
- 入组人数
- 150
- 主要终点
- Assess the safety of ABT-263 by evaluating study drug exposure, adverse events, serious adverse events, all deaths, as well as changes in laboratory determinations and vital sign parameters.
研究概览
简要总结
This is a Phase 2b, open-label, multicenter, global study assessing the safety and efficacy of ABT-263 in subjects with B-cell CLL who have failed at least one prior fludarabine-containing regimen.
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
- •>= 18 yrs of age, have B-cell CLL, failed at least 1 prior fludarabine-containing regimen.
- •Refractory to 1 fludarabine-containing regimen is defined as failure to achieve at least PR to the last fludarabine-containing regimen received, or disease progression while receiving the last fludarabine-containing regimen, or disease progression in responders (i.e., achieved a PR or CR) within 6 mos of the last cycle of the last fludarabine-containing regimen received (e.g., fludarabine monotherapy, FR, or FC) or in responders (i.e., achieved a PR or CR ) within 24 mos of the last cycle of FCR.
- •Intolerant to fludarabine is defined as discontinuation of therapy within 2 cycles due to side effects/toxicity from the last fludarabine-containing regimen.
- •ECOG score of <=
- •Adequate coagulation, renal, & hepatic function at Screening as follows:
- •Serum creatinine <= 2.0 mg/dL or calculated creatinine clearance >= 50 mL/min;
- •AST & ALT <= 3.0 x ULN;
- •Bilirubin <= 1.5 x ULN.
- •Gilbert's Syndrome may have a Bilirubin > 1.5 x ULN; aPTT, PT, not to exceed 1.2 x ULN.
- •Adequate bone marrow (BM) independent of any growth factor support (with the exception of subjects with BM heavily infiltrated with underlying disease [80% or more] who may use growth factor support to achieve adequate BM) at Screening as follows:
- •ANC >= 1000/µL;
- •Platelets >= 75,000/mm3 (entry platelet count must be independent of transfusion within 14 days of Screening);
- •Hemoglobin >= 9.0 g/dL.
- •History of autologous BM transplant must be > 6 mos post transplant (prior to the 1st dose of study drug) & have adequate BM independent of any growth factor support (with the exception of subjects with BM that is heavily infiltrated with underlying disease [80% or more] who may use growth factor support to achieve adequate BM) at Screening as follows:
- •ANC >= 1500/µL;
- •Platelets >= 125,000/mm3;
- •Hemoglobin >= 10.0 g/dL.
- •Female subjects must be surgically sterile, postmenopausal (at least 1 year), or have negative results on a pregnancy test.
- •All female subjects not surgically sterile or postmenopausal (at least 1 year) & non-vasectomized male subjects must practice birth control.
排除标准
- •History/clinically suspicious for cancer-related CNS disease.
- •Undergone allogeneic stem cell transplant.
- •Undergone autologous stem cell transplant w/i 6 mos prior to 1st dose.
- •History/predisposing condition of bleeding or currently exhibits signs of bleeding.
- •Recent history of non-chemotherapy induced thrombocytopenic associated bleeding w/i 6 mos prior to 1st dose.
- •Active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
- •Active immune thrombocytopenic purpura or history of being refractory to platelet transfusions w/i 1 yr prior to 1st dose.
- •Currently receiving/requires anticoagulation therapy or any drugs or herbal supplements that affect platelet function, with the exception of low-dose anticoagulation medications used to maintain the patency of a central IV catheter.
- •Significant history of cardiovascular disease, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease.
- •Positive for HIV, Hepatitis B, or Hepatitis C.
- •Previous or current malignancies w/i the last 3 yrs:
- •except adequately treated in situ carcinoma of the cervix uteri;
- •basal or squamous cell carcinoma;
- •in situ carcinoma of the bladder;
- •or previous malignancy confined and surgically resected with curative intent.
- •Has Prolymphocytic leukemia or Richter's transformation to an aggressive B-cell malignancy.
- •Exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to uncontrolled systemic infection or diagnosis of fever and neutropenia w/i 1 week prior to study drug.
- •Prior exposure to ABT-
- •Received antibody therapy w/i 30 days prior to 1st dose.
- •Received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, or any investigational therapy w/i 14 days prior to the 1st dose, or has not recovered to <Gr2 clinically significant AE(s) /toxicity(s) of the previous therapy.
- •Received steroid therapy for anti-neoplastic intent, w/i 7 days prior to the 1st dose with the exception of inhaled steroids for asthma, topical steroids, or replacement/stress corticosteroids.
- •Received aspirin w/i 7 days prior to the 1st dose.
- •Consumed grapefruit or grapefruit products w/i 3 days prior to 1st dose.
- •Females pregnant or breast-feeding.
研究组 & 干预措施
1
Experimental
干预措施: ABT-263 (Drug)
结局指标
主要结局
Assess the safety of ABT-263 by evaluating study drug exposure, adverse events, serious adverse events, all deaths, as well as changes in laboratory determinations and vital sign parameters.
时间窗: monthly (at a minimum)
Assess the objective response rate (partial response [PR] and confirmed complete response [CR]) of B-cell CLL subjects treated with ABT-263.
时间窗: Every 3 months
次要结局
- Assess the effects of ABT-263 on duration of overall response, PFS and overall survival in subjects with B-cell CLL.(Every 3 months)
- Assess the effects of ABT-263 on time to response, 12-month survival rate, time to disease progression (TTP), and disease control rate in subjects with B-cell CLL .(Every 3 months)
- Investigate the effects of ABT-263 on quality of life (FACT-Leu and EQ-5D), ECOG performance status, and biomarkers in subject with B-cell CLL.(Every 3 months)
研究者
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