NCT00955812已完成1 期
A Phase I, Open-label, Dose Escalation, Non-randomized Study to Assess the Pharmacokinetics, Dose Limiting Toxicity, and Maximum Tolerated Dose of OPB-31121 in Subjects With Advanced Solid Tumors
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
- 24
- 试验地点
- 2
- 主要终点
- Maximum Tolerated Dose (MTD) of OPB-31121
研究概览
简要总结
The goal of this clinical research study is to find the highest tolerable dose of OPB-31121 that can be given to patients with an advanced solid tumor. The safety of this drug will also be studied.
详细描述
The Study Drug:
OPB-31121 is designed to block certain proteins in cancer cells that cause the cancer cells to reproduce and form more cancer cells.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of OPB-31121 based on when you joined this study. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of OPB-31121 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
- •Subjects with histologically or radiologically confirmed solid tumors refractory to standard therapy, for which there is no standard therapy, or are not eligible for standard therapy. Subjects must have at least one measurable lesion.
- •Male and female subjects >/= 18 years of age.
- •Male and female subjects who are surgically sterile; female subjects who have been postmenopausal for at least 12 consecutive months; or male and female subjects who agree to remain abstinent or to begin TWO acceptable methods of birth control from one week prior to drug administration through 30 days (for females) and 90 days (for males) from the last dose of study medication. If employing birth control, two of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device (IUD), condom, diaphragm, cervical cap or sponge with spermicide.
- •Eastern Cooperative Oncology Group (ECOG) performance status: </= 2
- •Subjects must have a life expectancy of longer than 3 months.
- •Adequate vital organ function as follows: Neutrophils: >/= 1,500/microliter; platelets: >/= 75,000/microliter; hemoglobin: >/= 9.0 g/dL; Aspartate transaminase (AST), Alanine transaminase (ALT): </= 2.5 * ULN with the exception of subjects with liver metastases. In these cases, AST, ALT </= 5 * ULN for eligibility; serum total bilirubin: < 2.5 * ULN. Subjects must have a normal serum creatinine with a measured 24 hour creatinine clearance of > 60 cc/min; INR < 1.5
- •Ability to provide written informed consent prior to initiation of any study-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the study.
- •Subjects, who have received prior therapy, eg, chemotherapy, radiotherapy, or surgery, must have stopped therapy for >/= 4 weeks prior to drug administration. Subjects who have received targeted or immunotherapy must have stopped therapy for 5 half lives or 4 weeks prior to drug administration, whichever is earlier, and recovered from any prior toxicity not mentioned above to at least Grade
- •Subjects must have a normal ejection fraction (>/= 50%) as measured by either echocardiogram or multi gated acquisition (MUGA) scan.
排除标准
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Known central nervous system (CNS) metastasis.
- •Presence of active gastrointestinal disease or other condition (eg, significant bowel resections) which has the potential to significantly affect the absorption of the study drug, in the opinion of the investigator or sponsor.
- •Known history of or concurrent hepatitis or acquired immunodeficiency syndrome (AIDS) or known carriers of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (anti-HCV), or human immunodeficiency virus (HIV) antibodies.
- •Subjects who are pregnant or breast feeding. A negative urine pregnancy test must be confirmed prior to the first dose of study drug for women of child bearing potential (WOCBP).
- •Administration of another investigational agent within 28 days or 5 half-lives for targeted therapy or immunotherapy (whichever is shorter) prior to study entry
- •Use of prohibited medications
- •Subjects with history of coagulopathy (or taking anticoagulants) including deep vein thrombosis (DVT)/pulmonary embolism (PE), myocardial infarction or stroke within the last 6 months.
研究组 & 干预措施
OPB-31121
Experimental
OPB-31121 50 mg by mouth 2 times a day on Days 1-21 of each 28-day cycle.
干预措施: OPB-31121 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of OPB-31121
时间窗: 4 Week Cycle
The MTD is defined as the highest dose level at which \< 2 of 6 subjects experience dose limiting toxicity (DLT) during the first cycle.
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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