A Phase I Clinical Study of Oral CP-4126 in Patients With Advanced Solid Tumour
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 3
- 主要终点
- Step 1: MTD of oral CP-4126 in patients with advanced solid tumours, followed by establishing the recommended dose
研究概览
简要总结
At step 1, patients with advanced solid tumors will receive CP-4126 capsules following a dose escalation schedule until the maximum tolerated dose is reached. At step 2, 20 patients will be randomized. They will receive at days 1 and 8 in a double cross design either oral CP-4126 at the recommended dose or gemcitabine 1000mg/m2 intravenously. At both steps, the schedule of treatment will be day 1, 8, 15 q4w until complete response or disease worsening/ progressing. All further treatment at step 2 will be oral CP-4126.
详细描述
This is a multicentre clinical study conducted in Belgium and in The Netherlands. The study is a phase I divided in 2 steps: The first step is a dose escalation to define the RD. At the second step the PK profile of oral CP-4126 will be compared with the PK profile of IV gemcitabine. In addition, the study is conducted to characterize the tolerability of oral CP-4126, to evaluate its bioavailability, and to make a preliminary assessment of antitumor activity in patients with solid tumours.
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
- •Histologically or cytologically confirmed solid tumour diagnosis
- •Locally advanced or metastatic disease, for which there is no known effective treatment
- •Performance Status 0 - 2 according to ECOG (Eastern Cooperative Oncology Group) Performance Status
- •Age 18 years or more
- •Life expectancy > 3 months
- •Adequate hematological and biological functions:
- •Signed informed consent
排除标准
- •Symptomatic brain metastases
- •Current peripheral neuropathy of grade > 1 according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
- •Radiotherapy
- •to more than 30 % of bone marrow
- •single dose up to 8 Gy
- •less than one week prior to the study treatment
- •of the upper GI tract
- •Mucositis of the upper digestive tract, including stomatitis
- •Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
- •Previous anticancer therapy (chemotherapy, hormone therapy or immunotherapy) within 30 days prior to the first dose of oral CP-4126 [6 weeks for mitomycin C and BCNU (= carmustine) and CCNU (=lomustine)]
- •Requirement of concomitant treatment with a non-permitted medication including alternative drugs and high doses of vitamins
- •History of allergic reactions to gemcitabine
- •Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection)
- •Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance
- •Pregnant or breast feeding women
- •Absence of adequate contraception for both male and female fertile patients for the duration of the study; and also for six months after last treatment
- •Known positive status for HIV and/or hepatitis B or C
- •Any reason why, in the investigator's opinion, the patient should not participate
- •Condition that impairs ability to swallow pills
- •Coeliac disease or any other lipid malabsorption syndrome
- •Drug and/or alcohol abuse
研究组 & 干预措施
1
Step 1: Dose escalation - oral CP-4126
Step 2: Oral CP-4126 on day 1 and 15 in a 4 week schedule. One dose (only) gemcitabine IV on day 8.
干预措施: CP-4126 (Drug)
1
Step 1: Dose escalation - oral CP-4126
Step 2: Oral CP-4126 on day 1 and 15 in a 4 week schedule. One dose (only) gemcitabine IV on day 8.
干预措施: Gemcitabine (Drug)
2
Step 1: Dose escalation - oral CP-4126
Step 2: Oral CP-4126 on day 8 and 15 in a 4 week schedule. One dose (only) gemcitabine IV on day 1.
干预措施: CP-4126 (Drug)
2
Step 1: Dose escalation - oral CP-4126
Step 2: Oral CP-4126 on day 8 and 15 in a 4 week schedule. One dose (only) gemcitabine IV on day 1.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Step 1: MTD of oral CP-4126 in patients with advanced solid tumours, followed by establishing the recommended dose
时间窗: 6 months
Step 2: Pharmacokinetic parameters comparison of oral CP-4126 with IV gemcitabine
时间窗: 12 months
次要结局
- Preliminary assessment of antitumor activity of oral CP-4126(18 months)
- Tolerability of oral CP-4126(12 months)
- Biovailability of oral CP-4126(12 months)