NCT00387608已完成1 期
A Phase 0 Pharmacokinetic, Pharmacodynamic Study of ABT-888, an Inhibitor of Poly (ADP-ribose) Polymerase (PARP), in Refractory Solid Tumors and Lymphoid Malignancies
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Change in tumor poly (ADP-ribose) (PAR) levels from baseline to 3-6 hours after ABT-888 administration
研究概览
简要总结
RATIONALE: ABT-888 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about the ways a patient's body handles the drug.
PURPOSE: This early phase I trial is studying the side effects and best dose of ABT-888 in patients with refractory solid tumors or hematologic cancer.
详细描述
OBJECTIVES:
Primary
- Determine the dose-range at which ABT-888 inhibits poly (ADP-ribose) polymerase (PARP) in tumor samples and in peripheral blood mononuclear cells (PBMCs) in patients with refractory solid tumors or lymphoid malignancies.
- Determine the pharmacokinetics of ABT-888.
- Determine the time course of PARP inhibition in PBMCs by ABT-888.
Secondary
- Determine the safety of administering 1 dose of ABT-888 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed malignancy, meeting 1 of the following criteria:
- •Solid tumor that is refractory to ≥ 1 line of standard treatment OR for which no standard therapy is available
- •Must have ≥ 1 lesion amenable to percutaneous biopsy (for solid tumor patients enrolled after the initial phase of the study)
- •Chronic lymphocytic leukemia (CLL) or follicular lymphoma with no current indication for standard therapy OR disease that has failed ≥ 1 line of standard therapy
- •No disease-associated symptoms requiring immediate therapy or other interventions
- •Must be willing to undergo tumor biopsies* after the initial phase of the study NOTE: *Patients with CLL undergo peripheral blood collection instead of biopsy
- •No primary brain tumors, brain metastases, or leptomeningeal disease
- •PATIENT CHARACTERISTICS:
- •ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
- •Life expectancy ≥ 3 months
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 9 g/dL
- •Bilirubin < 1.5 times upper limit of normal (ULN)
- •AST and ALT ≤ 2.5 times ULN
- •Creatinine < 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
- •INR ≤ 1.4
- •PTT ≤ 36 seconds
- •Calcium (corrected) normal
- •Magnesium < 1.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 30 days after study completion
- •No history of seizures
- •No evidence of bleeding diathesis
- •No uncontrolled intercurrent illness including, but not limited to, any of the following:
- •Ongoing or active infection
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Cardiac arrhythmias
- •No psychiatric illness or social situations that would limit study compliance
- •PRIOR CONCURRENT THERAPY:
- •At least 2 weeks since prior radiation therapy or surgery and recovered
- •At least 2 weeks since other prior therapy and recovered
- •No concurrent antiretroviral therapy for HIV-positive patients
- •No concurrent lung, liver, or mediastinal lymph node biopsies
- •No other concurrent investigational agents
排除标准
- 未提供
结局指标
主要结局
Change in tumor poly (ADP-ribose) (PAR) levels from baseline to 3-6 hours after ABT-888 administration
Pharmacokinetics
次要结局
- Safety of administering 1 dose of ABT-888
- Changes in PAR levels in peripheral blood mononuclear cells from baseline to after ABT-888 administration
研究者
研究点 (2)
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