Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 on Days 1 and 8 Every Three Weeks (q3wk) in Non-Colorectal Cancer (Non-CRC) Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Recommended dose (RD)
研究概览
简要总结
Phase I Study of PM01183 in Non-Colorectal Cancer Patients to determine the recommended dose (RD) of PM01183.
详细描述
Phase I Study of PM01183 in Non-Colorectal (non-CRC) Cancer Patients to determine the recommended dose (RD) of PM01183, to characterize the safety profile, compliance and feasibility of the schedule, to optimize and individualize PM01183 dosing in non-CRC patients according to individual tolerance, to characterize the pharmacokinetics (PK) of the schedule, to obtain preliminary information on the clinical antitumor activity and to perform an exploratory pharmacogenomics (PGx) analysis.
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
- •Voluntarily signed and dated written informed consent
- •Age ≥ 18 years.
- •Non or minimally daily activities-interfering disease related symptoms.
- •Life expectancy ≥ 3 months.
- •Patients with solid tumor other than CRC.
- •Adequate bone marrow, renal, hepatic, and metabolic function (tests within normal limits or only minimally altered as assessed ≤ 7 days before inclusion in the study)Recovery to asymptomatic or minimally altered or to baseline from any adverse event (AE) derived from previous treatment (mild alteration for alopecia, skin toxicity or fatigue are allowed).
- •Normal cardiac function cardiac function by appropriate image testing.
- •Women of childbearing potential must have a negative serum pregnancy test before study entry.
排除标准
- •Primary colorectal cancer diagnosis
- •Prior treatment with PM
- •Concomitant diseases/conditions:
- •a) History of a clinically relevant cardiac condition c) Known chronic liver disease. d) Active uncontrolled infection. e) Known human immunodeficiency virus (HIV) infection. f) Limitation of the patient's ability to comply with the treatment or follow-up protocol.
- •Symptomatic and progressive or corticosteroid-requiring documented brain metastases
- •Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding.
- •History of extensive prior pelvic irradiation.
- •History of previous bone marrow and/or stem cell transplantation.
研究组 & 干预措施
A
Patients will receive PM01183 on Days 1 and 8 q3wk (three weeks = one treatment cycle) as an i.v. infusion, starting at 3.0 mg/day, flat dose (FD), over a minimum total volume of 100 ml dilution (on 5% glucose or 0.9% sodium chloride) via a central catheter or over a minimum total volume of 250 ml via a peripheral line, over one hour (at a fixed rate) and through a pump device.
干预措施: PM01183 (Drug)
结局指标
主要结局
Recommended dose (RD)
时间窗: From treatment onset to end of treatment
To determine the recommended dose (RD) of PM01183 administered as a 1-hour infusion intravenously (i.v.) on Days 1 and 8 every three weeks (q3wk) in non-colorectal cancer (non-CRC) patients.
次要结局
- Pharmacokinetics (PK): The dose-exposure relationships for Cmax and area under the curve (AUC) will be evaluated.(During the infusions administered on Day 1 of Cycles 1 and 3, with a schedule of 13 samples.)
- Antitumor activity measured clinically and/or radiologically according to RECIST or by evaluation of tumor markers(Every six weeks while on treatment. Patients who discontinued treatment without disease progression will be followed every three months until disease progression, other antitumor therapy, death or until the end-of-study date, whichever occurs first.)
- Pharmacogenomics (PGx) analysis: Number of tumour patient samples with identified and validated putative molecular markers associated with the clinical outcome of non-CRC patients treated with PM01183.(At the end of the study (24 months))