NCT00243087已完成1 期
An Open Phase I Single Dose Escalation Study of BI 2536 Administered Intravenously in Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 4
- 主要终点
- Maximum tolerated dose as measured by CTCAE v3.0 at days 1-22 of each course
研究概览
简要总结
RATIONALE: BI 2536 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of BI 2536 in treating patients with refractory or relapsed advanced non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of BI 2536 in patients with refractory or relapsed advanced aggressive non-Hodgkin's lymphoma.
- Determine the safety and tolerability of this drug in these patients.
Secondary
- Determine the pharmacokinetic profile of this drug in these patients.
- Determine, preliminarily, the antitumor activity of this drug in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed advanced aggressive non-Hodgkin's lymphoma (NHL), including any of the following subtypes:
- •B-cell NHL, including any of the following subtypes:
- •Diffuse large B-cell lymphoma
- •Primary mediastinal (thymic) B-cell lymphoma
- •Intravascular large B-cell lymphoma
- •Immunoblastic B-cell lymphoma
- •Mantle cell lymphoma
- •Burkitt's lymphoma
- •Follicular grade 3b lymphoma
- •T-cell NHL, including any of the following subtypes:
- •Anaplastic large cell lymphoma
- •Peripheral T-cell lymphoma, not otherwise specified
- •De novo or transformed disease
- •Refractory (i.e., disease not amenable to standard therapy) or relapsed disease, as evidenced by 1 of the following:
- •Refractory to OR relapsed after ≥ 1 prior combination chemotherapy regimen
- •Refractory to OR relapsed after prior CD20-based immunotherapy (for patients eligible to receive such therapy)
- •Refractory after prior high-dose chemotherapy and autologous stem cell transplantation AND ≥ 100 days post transplantation
- •At least 1 bidimensionally measurable lesion ≥ 1.5 cm by CT scan, MRI, x-ray, or clinical examination
- •No active CNS lymphoma
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,000/mm^3
- •Platelet count ≥ 75,000/mm^3
- •Hemoglobin ≥ 9 g/dL
- •No known coagulopathy
- •ALT and/or AST ≤ 2.5 times upper limit of normal (ULN) (< 5 times ULN if due to hepatic lymphoma)
- •Bilirubin ≤ 1.5 times ULN
- •Creatinine ≤ 2.0 mg/dL
- •Immunologic
- •No known HIV infection
- •No serious active infection that requires IV antibiotics or antifungal or antiviral agents
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective double-method contraception during and for 1 year after completion of study treatment
- •No known or suspected alcohol or drug abuse
- •No sensory or motor neuropathy ≥ grade 3
- •No other malignancy within the past 5 years except nonmelanoma skin cancer
- •No other life-threatening illness or organ dysfunction that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- •See Radiotherapy
- •More than 3 weeks since prior and no concurrent immunotherapy
- •No prior allogeneic bone marrow transplantation
- •Chemotherapy
- •See Disease Characteristics
- 另有 9 项未显示
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose as measured by CTCAE v3.0 at days 1-22 of each course
时间窗: up to 22 days of each course
Dose-limiting toxicity as measured by CTCAE v3.0 at days 1-22 of each course
时间窗: up to 22 days of each course
次要结局
- Objective tumor response by CT scan or MRI as measured by RECIST criteria on day 22 of each even numbered course(day 22 of every second course)
- Pharmacokinetics as measured in blood samples at days 1, 2, 3, and 8 during first course and on day 1 of each subsequent course(day 22 of each course)
研究者
研究点 (4)
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