NCT00831636已完成1 期
A Phase I/II Study of CP-4055 in Patients With Platinum Resistant Ovarian Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 5
- 主要终点
- Phase I: Determine recommended dose for phase II studies of CP-4055 when given five consecutive days twice in a 4 week schedule, D1-5 and D8(+2)-12(+2) q4w
研究概览
简要总结
This is non randomised, open label, dose finding, efficacy and safety study, enrolling patients with advanced (stage III and IV) ovarian cancer It will be conducted in two successive phases. Phase II has a two-step design
详细描述
Phase I
- Three eligible patients will be enrolled at each dose level (DL), according to standard dose escalation decision rules
- Patients will receive CP-4055 at increasing DLs until the maximum tolerated dose and the recommended dose (RD) have been established
Phase II
-
Step 1 (The patient inclusion may stop after this step):
-
Patients will be enrolled at the RD until there are maximum 16 evaluable patients at this DL
-
Step 2:
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically documented advanced epithelial ovarian cancer measurable with CT and/or MRI
- •Received prior chemotherapy regimen(s) for ovarian cancer, at least one being a platinum based therapy (PBT)
- •Evidence of platinum resistant or refractory disease
- •ECOG Performance Status 0 - 1
- •Life expectancy > 3 months
- •Signed informed consent (IC)
- •Women of child-bearing potential must have a negative serum or urine pregnancy test. Nursing patients are excluded.
- •Women of child-bearing potential must not become pregnant while participating in the study
- •Adequate haematological and biological functions
排除标准
- •Patients with mixed mullerian tumours (MMT) (carcinosarcomas)
- •Known brain metastases
- •Another known active cancer within the last 5 years
- •Radiotherapy to more than 30 % of bone marrow
- •Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
- •Concomitant treatment with a non-permitted medication
- •A history of allergic reactions or sensitivity attributed to compounds of similar or biological composition to CP-4055, i.e., ara-C and/or egg
- •Any serious concomitant systemic disorders incompatible with the clinical study
- •Any significant CNS or psychiatric disorder(s) that would hamper the patient's compliance
- •Pregnancy or breastfeeding
- •Known positive status for HIV and/or hepatitis B or C
- •Drug and/or alcohol abuse
- •Any reason why, in the investigator's opinion, the patient should not participate
研究组 & 干预措施
Open label CP-4055
Experimental
Phase I: Dose escalation Phase II: Fixed dose
干预措施: CP-4055 (Drug)
结局指标
主要结局
Phase I: Determine recommended dose for phase II studies of CP-4055 when given five consecutive days twice in a 4 week schedule, D1-5 and D8(+2)-12(+2) q4w
时间窗: August 2009/June 2010
Phase II: Determine the antitumour activity of CP-4055
时间窗: August 2009/June 2010
次要结局
- Explore the time to progression (TTP)(August 2009/June 2010)
- Investigate the duration of tumour response(August 2009/June 2010)
- Determine the nature and degree of toxicity of CP-4055 in this patient population(August 2009/June 2010)
- Determine pharmacokinetic (PK) parameters(August 2009/June 2010)
研究者
研究点 (5)
Loading locations...
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