Phase I Dose Escalating Study Of Tas-106 In Combination With Carboplatin In Patients With Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
The goal of this clinical research study is to find the highest safe dose of the combination of TAS-106 and carboplatin that can be given to patients with advanced cancer or cancer that has spread.
Objectives:
Primary Objectives:
To determine the maximum tolerated dose (MTD) of the combination of TAS-106 and carboplatin administered by intravenous infusion every 3 weeks.
To perform Pharmacokinetic (PK) analysis of TAS-106 and carboplatin
Secondary objectives:
To assess the antitumor activity of TAS-106 combined with carboplatin
To investigate the relationship between selected biomarkers and efficacy and safety outcomes.
详细描述
The Study Drugs:
TAS-106 and carboplatin are designed to interfere with the growth of cancer cells by stopping cell division, which may cause the cells to die.
Study Drug Dose Level:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of the study drug combination that is based on when you joined this study. Up to 6 dose levels of the study drug combination will be tested. Three (3) participants will be enrolled at each dose level. If no intolerable side effects occur in the first group of 3 people, the next 3 people enrolled in the study will receive the same dose of carboplatin and a higher dose of TAS-106. If this second group has no intolerable side effects, the next 3 people will receive a higher dose of carboplatin while receiving the same dose of TAS-106 as the second group. This will continue until the highest safe dose combination is found.
Study Drug Administration:
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
- •Histologically or cytologically confirmed diagnosis of a solid tumor. Advanced or metastatic disease that is refractory to standard therapy or for which no standard therapy exists
- •Objective evidence or disease recurrence or metastatic disease
- •Age >/= 18 years old at study entry
- •Measurable or evaluable disease
- •A score of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale
- •Hemoglobin > 9.0 g/dL; Platelet count >/=100,000/uL; Absolute neutrophil count (ANC) >/=1500/uL
- •Serum creatinine </=1.5 mg/dL; if > 1.5mg/dL, then a calculated creatinine clearance must be >/=60 mL/min
- •Total bilirubin </=1.5 mg/dl; ALT </= 2 times the upper limit of normal (ULN) (may be </= 5 times ULN if due to metastatic disease in the liver).
- •Fertile men and women, and their partners, must use a medically effective contraception method (spermicide with male or female condoms, cervical sponge, IUD, cervical cap, or diaphragm or oral, implantable, transdermal, or injectable contraceptives) throughout the treatment period and for 30 days after the last dose of study medication. Premenopausal women of reproductive capacity and women less than 12 months after menopause must have a negative pregnancy test documented prior to study entry.
- •Signed written informed consent per institutional and federal regulatory requirements.
排除标准
- •Has known hypersensitivity to carboplatin
- •Radiological or clinical evidence of brain involvement or leptomeningeal disease
- •Have history of Human Immunodeficiency Virus, hepatitis B, or hepatitis C infection
- •>/=grade 2 peripheral neuropathy
- •Women who are pregnant or breast feeding.
- •Serious illness or medical condition(s) including but not limited to the following: a) Congestive heart failure or uncontrolled angina pectoris. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or dysrhythmias. b) Active infection. c) Unstable diabetes mellitus. d) Psychiatric disorder that may interfere with consent and/or protocol compliance
- •Female or male subject of reproductive capacity who is unwilling to use methods appropriate to prevent pregnancy during the course of this study.
- •Receiving concurrent chemotherapy, investigational agents radiotherapy, or surgery.
- •Received radiation therapy to >30% of bone marrow (e.g., whole of pelvis or half of spine).
- •Received any investigational drug within the last 30 days.
- •Not fully recovered from any prior surgery (at least 4 weeks recovery period for major surgery), and from any reversible side effects related to the administration of cytotoxic chemotherapy, investigational agents, or radiation therapy.
研究组 & 干预措施
Carboplatin + TAS-106
Carboplatin starting dose AUC of 4, administered by vein over 60 minutes, Day 1 of 3 Week Cycle. TAS-106 starting dose 2.0 mg/m^2 by vein over 24 hours, Day 1 of 3 Week Cycle.
干预措施: TAS-106 (Drug)
Carboplatin + TAS-106
Carboplatin starting dose AUC of 4, administered by vein over 60 minutes, Day 1 of 3 Week Cycle. TAS-106 starting dose 2.0 mg/m^2 by vein over 24 hours, Day 1 of 3 Week Cycle.
干预措施: Carboplatin (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: With every 3 week cycle
次要结局
- To review relationship between selected biomarkers and efficacy/safety outcomes.(2 years)