NCT00848601终止1 期
Safety Study to Determine the Maximum Tolerated Dose, Pharmacokinetics and Pharmacodynamics of SGI-1776, a PIM Kinase Inhibitor, in Subjects With Hormone and Docetaxel Refractory Prostate Cancer and Relapsed/Refractory Non Hodgkin's Lymphoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 6
- 主要终点
- MTD & DLT
研究概览
简要总结
Patients with hormone and docetaxel refractory prostate cancer or relapsed/refractory non-Hodgkin's lymphoma for which no available standard therapy or therapy which may provide clinical benefit is available will be enrolled. Primary objectives: estimate the maximum tolerated dose and dose-limiting toxicities. Secondary objectives: Response rate, pharmacokinetic and pharmacodynamic profiles, Prostate Specific Antigen response and renal elimination.
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
- Other
- 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
- •Read, understand and sign the IRB- or IEC-approved ICF confirming his or her willingness to participate in this trial.
- •At least 18 years old.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Adequate bone marrow function; normal renal and hepatic function, normal cardiac function.
- •Normal cardiac function in the opinion of the investigator and supported by LVEF 50% or greater on the screening echocardiogram (or MUGA), no significant abnormalities on the screening ECG (eg, left bundle branch block, III degree AV block, acute myocardial infarction, Wolff-Parkinson-White syndrome or QTc interval ≥ 450 msec) and no history of additional risk factors for torsades de pointes (eg, heart failure, hypokalemia or family history of Long QT Syndrome).
排除标准
- •Active secondary malignancy or history of other malignancy within the last two years except non-melanoma skin cancers or cervical carcinoma in situ.
- •History of significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure and/or myocardial infarction or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification.
- •Received any anticancer agent(s) within the past 3 weeks, including investigational agents, chemotherapy (6 weeks for nitrosoureas or mitomycin), immunotherapy, biologic or marketed or investigational tyrosine kinase inhibitors.
- •Received prior radiation therapy within the past 4 weeks or received irradiation of ≥ 25% of their bone marrow reserve.
- •Any serious, uncontrolled active infection that requires systemic treatment or known infection with HIV, HCV or HBV.
- •Symptomatic CNS metastases or lesions for which treatment is required.
- •Prostate Cancer
- •Inclusion Criteria:
- •Males with histologically confirmed adenocarcinoma of the prostate, which is now metastatic (e.g., any T, any N, M1a-c)based on bone scan, CT scan, or MRI scan. Demonstrated evidence of progressive disease despite androgen deprivation (androgen ablation or surgical castration), anti-androgen withdrawal and progression of disease after docetaxel-based therapy.
- •Demonstrated evidence of progressive disease despite androgen deprivation (androgen ablation or surgical castration), anti-androgen withdrawal and progression of disease after docetaxel-based therapy.
- •Greater than 25% increase in 3 consecutive tests (PSA 1 < PSA 2 < PSA 3), each PSA value separated by at least 1 week
- •Serum testosterone level ≤ 50 ng/dL post orchiectomy or while maintained on continuous or intermittent medical androgen suppression with a LHRH agonist or antagonist.
- •At least 4 weeks since prior flutamide, megestrol, ketoconazole, aminoglutethimide; and at least 6 weeks since prior bicalutamide or nilutamide.
- •Systemic corticosteroids discontinued within two weeks of dosing, except low dose regimens which may continue if unchanged
- •Strontium-89 or Samarium-153 must have been completed at least 8 weeks prior to the first dose of therapy and recovered from all treatment-related toxicities.
- •Exclusion Criteria:
- •Must not be receiving concurrent anti-androgen hormonal therapy for hormone refractory prostate cancer.
- •Non-Hodgkin's Lymphoma
- •Inclusion Criteria:
- •Histologically proven relapsed or refractory non-Hodgkin's lymphoma subjects for which there is no available standard therapy or therapy which may provide clinical benefit.
- •Measurable disease (at least 1 lesion ≥ 1.5 cm).
- •Exclusion Criteria:
- •Bulky disease by CT, defined as any single mass >10 cm in its greatest diameter.
- •Systemic corticosteroids within 2 weeks, except low dose regimens which may continue if unchanged.
- •Received any radiopharmaceutical therapy within the past six weeks.
结局指标
主要结局
MTD & DLT
时间窗: July 2011
次要结局
- Response rate, pharmacokinetics, PSA response, renal elimination and pharmacodynamic effects on biomarker modulation.(July 2011)
研究者
研究点 (6)
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