An Open-Label Phase 1 Study to Investigate the Safety and Maximum Tolerated Dose of INNO-206 (Doxorubicin-6-Maleimidocaproyl Hydrazone; DOXO-EMCH) Administered as a 30 Minute Infusion Every 3 Weeks in Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
This is a phase 1b open-label study evaluating the preliminary safety and maximum tolerated dose of a new formulation of INNO-206 administered at doses of 230 mg/m2, 350 mg/m2 and 450 mg/m2 (165, 260, 325 mg/m2 doxorubicin equivalents, respectively) through intravenous infusion on Day 1 every 21 days for up to 6 cycles.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70 years, male or female.
- •Histologically or cytologically confirmed malignant solid tumor that has relapsed or is refractory to standard therapy.
- •Subjects who have received prior radiation therapy with stable CNS metastasis with no progression of brain metastasis by CT/MRI scan in last 4 weeks.
- •Capable of providing informed consent and complying with trial procedures.
- •ECOG performance status 0-
- •Life expectancy >12 weeks.
- •Measurable or evaluable disease according to RECIST 1.1 criteria.
- •Women must not be able to become pregnant (e.g. post menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study.
- •Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
- •Geographic accessibility to the site.
排除标准
- •Palliative surgery, chemotherapy, immunotherapy and/or radiation less than 4 weeks prior to the Screening Visit.
- •Exposure to any investigational agent within 30 days of the Screening Visit.
- •Laboratory values: Screening serum creatinine greater than or equal to 1.5 mg/dL, alanine aminotransferase (ALT) greater than 3 times the upper limit of normal, total bilirubin greater than 3 times the upper limit of normal, white blood cell (WBC) count < 3500/mm3, absolute neutrophil count < 2000/mm3, platelet concentration < 100,000/mm3, hematocrit level < 33% for females or < 35% for males, or coagulation tests (PT,PTT) >1.5 times the upper limit or normal.
- •Clinically evident congestive heart failure > class II of the New York Heart Association (NYHA) guidelines.
- •Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
- •History or signs of active coronary artery disease with or without angina pectoris.
- •Serious myocardial dysfunction defined scintigraphically (MUGA, myocardial scintigram)or ultrasound determined absolute left ventricular ejection fraction (LVEF) < 45% of predicted.
- •History of HIV infection.
- •Active, clinically significant serious infection requiring treatment with antibiotics, antivirals or antifungals.
- •Major surgery within 3 weeks prior to treatment.
- •Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.
- •Any condition that is unstable and could jeopardize the subject's participation in the study.
研究组 & 干预措施
INNO-206
INNO-206 at dosages of 230, 350, and 450 mg/m2 doxorubicin equivalents of 165, 260, and 325 mg/m2)will be administered as a 30 minute IVI on Day 1 of each cycle.
干预措施: INNO-206 (Drug)
结局指标
主要结局
Safety
时间窗: Up to 6 cycles (every 21 days)
Safety will be based on adverse events, tolerability, physical examinations, vital signs, ECG results, laboratory test results. MTD: If 2 of 5 subjects an any dose level experiences a grade 3 or 4 non-hematologic toxicity, or a platelet count \<25,000/uL or a neutrophil count \<500/uL lasting \>7 days and/or associated with fever \>38.5C, 3 more subjects will be entered at that dose level. If 2 of 3 of the additional subjects experience any of the above adverse events, the dose level immediately below will be identified as the MTD.
次要结局
- Objective response rate(Up to 6 cycles (every 21 days))