NCT00935844已完成1 期
An Open-Label, Dose Escalation, Phase I Study of TAK-901 in Adult Patients With Advanced Solid Tumors or Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- To identify the MTD of TAK-901 administered as either a 3-hour or 1-hour infusion.
研究概览
简要总结
This study is being conducted to evaluate the safety profile and the Maximum Tolerated Dose (MTD) of TAK-901 in adult patients with advanced solid tumors or lymphoma. This study will help to identify the recommended phase 2 dose and infusion duration, and describe the pharmacokinetics of TAK-901.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Each patient must meet all of the following criteria to be enrolled in the study:
- •ECOG performance status of < or equal to
- •Diagnosis of solid tumor malignancy or lymphoma for which standard treatment is no longer effective.
- •Have a radiographically or clinically evaluable tumor or lymphoma.
- •Measurable disease as described in the protocol.
- •Suitable venous access for the study-required blood sampling.
- •Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse.
- •Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse.
- •Voluntary written consent.
- •Weigh at least 45 kg.
- •Recovered from the reversible effects of prior antineoplastic therapy.
- •Meet clinical laboratory values during the screening period as specified in the protocol.
- •Left ventricular ejection fraction (LVEF) > or equal to 50% by echocardiogram or multiple acquisition scan (MUGA).
排除标准
- •Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- •Diagnosis of primary CNS malignancy or carcinomatous meningitis.
- •Patient has symptomatic brain metastasis.
- •Prior bone allogeneic bone marrow or stem cell transplant.
- •Prior radiotherapy involving > or equal to 30% of the hematopoietically active bone marrow, within 21 days before the start of the study drug.
- •Systemic antineoplastic therapy within 28 days before the start of the study drug, except for luteinizing hormone-releasing-hormone (LHRH) agonist therapy.
- •Exposure to nitrosureas or mitomycin C within 42 days before the start of the study drug.
- •Treatment with monoclonal antibodies within 28 days before the start of the study drug.
- •Known allergy or hypersensitivity to compounds of similar chemical composition to TAK-901 or its excipient, Captisol.
- •Female patients who are lactating or who have a positive serum pregnancy test during the screening period or a positive serum pregnancy test during the screening period.
- •Myocardial infarction within 6 months before enrollment.
- •Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- •Abnormalities on 12-lead electrocardiogram (ECG) as specified in the protocol.
- •Infection requiring systemic anti-infective therapy within 14 days before the start of study drug.
- •Known human immunodeficiency virus (HIV)positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection.
- •Diagnosed or treated for another malignancy within 2 years before the start of study drug or previously diagnosed with another malignancy and have any evidence of residual disease.
- •Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment.
- •Treatment with any investigational products within 28 days before the first dose of study drug.
- •Systemic use of strong CYP3A inhibitors or inducers (as specified in the protocol) within 14 days before the first dose of study drug.
研究组 & 干预措施
TAK-901 Arm
Experimental
干预措施: TAK-901 (Drug)
结局指标
主要结局
To identify the MTD of TAK-901 administered as either a 3-hour or 1-hour infusion.
时间窗: 12 months
To adaptively adjust the estimate of the MTD of TAK-901 from the escalation phase in an expansion cohort of subjects.
时间窗: 12 months
次要结局
- To evaluate the pharmacokinetic profile of TAK-901 and its primary metabolite (M-I).(12 months)
- To evaluate disease response.(12 months)
- To investigate the effect of TAK-901 on tumor proliferation.(12 months)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
1 期
Study of Oral Ixazomib in Adult Participants With Relapsed and/or Refractory (RR) Multiple MyelomaRelapsed and Refractory Multiple MyelomaNCT00932698Millennium Pharmaceuticals, Inc.60
已完成
1 期
A Study Evaluating BSI-201 in Combination With Chemotherapeutic Regimens in Subjects With Advanced Solid TumorsTumorsNCT00422682Sanofi136
终止
1 期
Dose Escalation of IPI-493 in Hematologic MalignanciesHematologic MalignanciesNCT01193491Infinity Pharmaceuticals, Inc.4
已完成
1 期
Study Evaluating Gefitinib (IRESSA®) in Subjects With Solid Malignancies That Are Locally Advanced, Recurrent or MetastaticTumorsNCT00127829AstraZeneca66
终止
1 期
A Safety, Tolerability and Pharmacokinetics Study of TransCon Treprostinil in Healthy Adult Male VolunteersHealthy VolunteersNCT03803163Ascendis Pharma A/S20