Phase I Multicenter, Open-label, Dose-escalating Clinical and Pharmacokinetic Trial of PM02734 Administered in Combination With Erlotinib in Patients With Advanced Malignant Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 3
- 主要终点
- To determine the safety and tolerability and to identify the dose limiting toxicity (DLT) and the recommended dose (RD) of the combination of PM02734 and erlotinib
研究概览
简要总结
Phase I multicenter, open-label, dose-escalating clinical and pharmacokinetic trial of PM02734 administered in combination with erlotinib to determine the safety and tolerability and to identify the dose limiting toxicity (DLT) and the recommended dose (RD) of the combination of PM02734 and erlotinib, in patients with advanced malignant solid tumors.
详细描述
Phase I multicenter, open-label, dose-escalating clinical and pharmacokinetic trial of PM02734 administered in combination with erlotinib to determine the safety and tolerability and to identify the dose limiting toxicity (DLT) and the recommended dose (RD) of the combination of PM02734 and erlotinib, determine the preliminary pharmacokinetics (PK) of the combination, evaluate the preliminary PK/pharmacodynamic correlation, evaluate the preliminary antitumor activity, perform a preliminary pharmacogenomic (PGx) study to explore molecular predictors of response to ErbB receptor antagonists and PM02734 in patient with advanced malignant solid tumors.
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
- •Voluntary written informed consent form.
- •Histologically or cytologically confirmed advanced malignant solid tumors.
- •Measurable or non-measurable disease following (RECIST)
- •Age ≥ 18 years.
- •Life expectancy ≥ 3 months.
- •Performance status ECOG ≤
- •Recovery from any drug-related adverse events (AEs) derived from previous treatments.
- •Appropriate bone marrow, liver and renal function.
- •Left ventricular ejection fraction (LVEF) within normal limits for the institution.
- •Women of childbearing potential must have a negative serum pregnancy test before study entry. Both men and women must agree to use a medically acceptable method of contraception throughout the treatment period and for three months after discontinuation of treatment.
排除标准
- •Prior therapy with PM
- •Pregnant or lactating women.
- •Less than four weeks from radiation therapy.
- •Evidence of progressive central nervous system (CNS) metastases. or any symptomatic brain or leptomeningeal metastases.
- •Other relevant diseases or adverse clinical conditions.
- •Any other major illness that, in the Investigator's judgment.
- •Limitation of the patient's ability to comply with the treatment or to follow-up at a participating protocol.
- •Ingestion of potent cytochrome CYP3A4 inhibitors.
- •Treatment with any investigational product in the 30-day period prior to the first infusion.
- •Known hypersensitivity to any component of PM02734 or erlotinib.
研究组 & 干预措施
Arm 1
Administration of i.v. infusions of PM02734 (on Days 1, 8 and 15) every three weeks and a daily oral dose of erlotinib
干预措施: PM02734 and erlotinib (Drug)
Arm 1
Administration of i.v. infusions of PM02734 (on Days 1, 8 and 15) every three weeks and a daily oral dose of erlotinib
干预措施: Erlotinib (Drug)
结局指标
主要结局
To determine the safety and tolerability and to identify the dose limiting toxicity (DLT) and the recommended dose (RD) of the combination of PM02734 and erlotinib
时间窗: 2 years
次要结局
- To determine preliminary: pharmacokinetics (PK) , PK / pharmacodynamic correlation, antitumor activity, pharmacogenomic (PGx) study to explore molecular predictors of response.(2 years)