Phase 1, Open-label, Multiple Dose Escalation Trial to Determine Safety and Tolerability of Once-Daily OPB-51602 in Subjects With Advanced Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- To determine the safety and tolerability of OPB-51602
研究概览
简要总结
The purpose of this study is to determine whether OPB-51602 is safe and tolerable when given daily by mouth to subjects with advanced solid tumors.
详细描述
This study is based on data that support a role for the signal transducer and activator of transcription (STAT) family of proteins in oncogenesis. One of the mechanisms of action of OPB-51602 includes inhibition of STAT3 phosphorylation. Therefore OPB-51602 is expected to be active as an anti-cancer drug. This first-in-human study will characterize the safety profile of OPB-51602, evaluate the pharmacokinetics of OPB-51602, identify a recommended phase II dose, and obtain preliminary efficacy data, in subjects with advanced cancers for whom there is no standard treatment available.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged ≥ 18 years
- •Pathologically confirmed advanced cancer that is resistant or refractory to standard therapy or for which no standard curative therapy is available
- •At least 4 weeks since the last dose of prior chemotherapy, radiation therapy, or investigational agent.
- •Subjects must have recovered from adverse effects of prior therapy at time of enrollment to ≤ Grade 1 (excluding alopecia)
- •ECOG performance status ≤ 1
- •Life expectancy of ≥ 3 months following study entry
- •Adequate organ function, defined as follows:
- •Serum creatinine < 1.5 x the upper limit of normal (ULN)
- •Aspartate aminotransferase and alanine aminotransferase levels ≤ 3.0 x ULN (≤ 5.0 x ULN in the presence of known liver metastasis)
- •Total bilirubin ≤ 1.5 x ULN
- •Alkaline phosphatase levels ≤ 2.5 x ULN (≤ 5 x ULN in presence of bone metastasis)
- •Absolute neutrophil count of ≥ 1,500/mm³ (≥ 1.5 x 10⁹/L)
- •Platelet count ≥ 100,000/mm³ (≥ 100 x10⁹/L)
- •Hemoglobin ≥ 9 g/dL
- •For women of childbearing potential (WOCBP), a negative serum pregnancy test result at screening and negative urine pregnancy test on Day 1
- •WOCBP or men whose sexual partners are WOCBP must agree to use 2 methods of adequate contraception
- •Before any protocol-specific screening procedures are performed, subjects must have signed and dated the IRB-approved ICF.
排除标准
- •Uncontrolled concurrent illness, including ongoing or active infection, uncontrolled hypertension,or any other condition that could raise the subject's safety risk.
- •Altered mental status, psychiatric illness, or social situation that could limit compliance with study requirements and/or confound interpretation of study results.
- •Known infection with human immunodeficiency virus, hepatitis B, or hepatitis C.
- •Known brain metastasis that has not been treated and stable for at least 4 weeks, or subjects with leptomeningeal disease.
- •Subjects unable to swallow oral medications or with pre-existing gastrointestinal disorders that might interfere with absorption of oral drugs.
- •A history of major surgery within 28 days of first receipt of study drug. Subjects must have recovered fully from any surgery.
- •Nursing or pregnant women
- •Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in opinion of investigator, contraindicates use of an investigational drug, or that may render subject at excessively high risk for treatment complications.
研究组 & 干预措施
OPDC-51602
Subjects with advanced solid tumors will be treated with OPDC-51602 once daily by mouth
干预措施: OPB-51602 (Drug)
结局指标
主要结局
To determine the safety and tolerability of OPB-51602
时间窗: Weekly for first cycle, then every 2 weeks (on average up to 8 weeks).
AEs, vital signs, body weight, ECGs, clinical laboratory tests, and performance status will be assessed.
次要结局
- Antitumor effects:(Every 2 cycles (on average 8 weeks).)
- To determine the pharmacokinetics of OPB-51602 and to determine the MTD of OPB-51602(28 days)
- Pharmacodynamic profile:(28 days)