NCT01335256已完成1 期
An Open-label, Phase I, Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of BAY1000394 Given in a 4 Week on / 2 Week Off Schedule in Subjects With Advanced Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 10
- 主要终点
- Number of subjects with Adverse Events as a measure safety
研究概览
简要总结
Clinical study to determine safety, tolerability, and maximum tolerated dose of BAY1000394 given in 4 week on / 2 week off schedule to patients with advanced solid tumors
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Life expectancy of at least 12 weeks
- •Subjects with advanced, histologically or cytologically confirmed solid tumors, refractory to any standard therapy, have no standard therapy available, or subjects must have actively refused any treatment which would be regarded standard, and / or if in the judgment of the investigator, experimental treatment is clinically and ethically acceptable
- •At least 1 tumor lesion measurable by computer tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST 1.1
- •Estimated creatinine clearance 60 mL/min according to Modification of Diet in Renal Disease Study Group (MDRD) formula(2)
- •Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the first dose of study drug
- •Subjects with a history of hypertension should be on a stable anti-hypertensive treatment for more than 7 days prior to the first dose of study drug
- •Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study-specific procedures.
排除标准
- •Any patient with potentially curable disease will be explicity excluded from enrollment into the study
- •Known hypersensitivity to the study drug (active investigational medicinal product or excipients of the preparations) or any agent given in association with this study
- •History of cardiac disease: congestive heart failure > NYHA Class II, unstable angina (anginal symptoms at rest), new-onset angina (within the past 3 months prior to study entry), myocardial infarction within the past 3 months prior to study entry, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
- •Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C(3)
- •History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
- •Symptomatic metastatic brain or meningeal tumors unless the subject is >3 months from definitive therapy, has no evidence of tumor growth on an imaging study within 4 weeks prior to study entry, and is clinically stable with respect to the tumor at the time of study entry. Subjects must not be on acute steroid therapy or taper off steroid therapy (chronic steroid therapy is acceptable provided that the dose is stable for 4 weeks prior to study entry and following screening CT / MRI scan). Subjects with neurological symptoms should undergo a CT / MRI scan of the brain to exclude new or progressive brain metastases. Spinal cord metastasis is acceptable
- •Previous or coexisting cancer that is distinct in primary site or histology from the cancer evaluated in this study EXCEPT cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors [Ta and Tis], or any cancer curatively treated >3 years prior to study entry
- •Anticancer chemotherapy or immunotherapy within 4 weeks of study entry. Mitomycin C or nitrosoureas should not be given within 6 weeks of study entry. Anticancer therapy is defined as any agent or combination of agents with clinically proven anti tumor activity administered by any route with the purpose of affecting the malignancy, either directly or indirectly, including palliative and therapeutic endpoints. Accepted exceptions are bisphosphonates, Luteinizing hormone-releasing hormone (LHRH) agonists for prostate cancer, and mitotane for adrenal carcinoma.
- •Radiotherapy to target lesions within 3 weeks prior to the first dose of study drug. Palliative radiotherapy will be allowed as described in Section 6.9 of this protocol. Radiotherapy to the target lesions during study will be regarded as progressive disease
- •Use of biological response modifiers, such as granulocyte-colony stimulating factor (G-CSF), within 3 weeks prior to the first dose of study drug. Granulocyte-colony stimulating factor (G-CSF) and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however, they may not be substituted for a required dose reduction
研究组 & 干预措施
Arm 1
Experimental
干预措施: BAY1000394 (Drug)
结局指标
主要结局
Number of subjects with Adverse Events as a measure safety
时间窗: Up to 3 years or longer if indicated
Maximum tolerated dose: Measured by adverse event profile
时间窗: Up to 3 years or longer if indicated
次要结局
- Biomarkers evaluation measured by Enzyme-linked immunosorbent assay (ELISA)(Up to 3 years or longer if indicated)
- Tumor Response evaluation measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)(Up to 3 years or longer if indicated)
- Peak Plasma Concentration (Cmax) of BAY1000394(Approximately 18 months)
- Pharmacokinetics parameters will be measured using Peak Plasma Time (tmax) of BAY1000394(Approximately 18 months)
- Area under the plasma concentration versus time curve from 0 to tn (AUC(0 tn)) of BAY1000394(Approximately 18 months)
- Area under the plasma concentration versus time curve (AUC) of BAY1000394(Approximately 18 months)
- Half-life of BAY1000394(Approximately 18 months)
研究者
相似试验
已完成
1 期
Open Label Study of BAY1082439 in Patients With Advanced CancerNeoplasmsNCT01728311Bayer60
已完成
1 期
Safety and Tolerability of BAY1862864 Injection in Subjects With Relapsed or Refractory CD22-positive Non-Hodgkin's LymphomaLymphoma, Non-HodgkinNCT02581878Bayer21
招募中
1 期
A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Temozolomide in Patients with Recurrent or Progressive Glioblastoma Multiforme (GBM)Glioblastoma MultiformeNCT05769660BeyondBio Inc.12
撤回
1 期
An Open-label Phase Ib/II Study of BAY 1000394 (Roniciclib) in Combination With Docetaxel in Second- or Third-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC)NSCLC (Non-Small Cell Lung Cancer)NCT02522910Yonsei University
已完成
1 期
A First-in-Humans Dose Finding Study for an Aryl Hydrocarbon Receptor Inhibitor (AhRi) in Patients With Advanced CancerAdvanced Solid TumorsNCT04069026Bayer78