EUCTR2004-001457-28-GB进行中（未招募）1 期
Phase II open label study of CT-2106 as a single agent in patients with advanced metastatic ovarian cancer who have failed one prior platinum and taxane based regimen
Cell Therapeutics Europe S.r.l0 个研究点目标入组 80 人开始时间: 2005年2月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Subjects with histologically proven advanced ovarian carcinoma, who have failed one prior platinum and taxane containing regimen; depending on the response to the prior platinum-taxane chemotherapy, patients will be classified as:
- •Platinum-refractory or platinum resistant patients (Group 1): patients with
- •progressive or stable disease while on 1st line therapy. Patients presenting a response during the 1st line therapy but progressing while still on 1st line therapy will be considered as refractory (platinum-refractory). Patients who responded (CR or PR) to a 1st line therapy and subsequently progressed or relapsed after a treatment-free interval < 6 months; treatment-free interval is defined as: time elapsing from the last day of 1st line therapy to the first day of second-line therapy start” (platinumresistant);
- •Platinum-sensitive patients (Group 2): Patients who responded (CR or PR) to a 1st
- •line therapy and subsequently progressed or relapsed after a treatment-free interval = 6 and = 12 months; treatment-free interval is defined as: time elapsing from the last day of 1st line therapy to the first day of second-line therapy start”
- •2. The patients must have recovered (= grade 1) from all side effects (except alopecia) of prior therapy (except for diarrhoea, which must be grade 0)
- •3. Only one prior chemotherapy containing either cisplatin or carboplatin plus taxanes
- •administered concomitantly
- •4. At least one measurable lesion according to RECIST
- •5. =18 years old
- •6. ECOG performance status = 1
- •7. Life expectancy of more than 3 months as assessed by the investigator;
- •8. Adequate haematological function: Haemoglobin = 10g/dl, ANC = 2.0 × 109/L, platelets = 100× 109/L
- •9. Adequate renal and hepatic functions: total bilirubin = 1.25 x ULN, creatinine = 1.25 ×ULN, ASAT and ALAT = 2.5 × ULN, alkaline phosphatases = 2.5 x ULN; in case of
- •liver metastases, ASAT, ALAT and alkaline phosphatases must be = 5 x ULN
- •10. Normal coagulation parameters (PT, aPTT, and INR)
- •11. Subjects must be willing and able to comply with scheduled visits and with management of toxicity
- •12. Patients with reproductive potential must be able to avoid a pregnancy during the whole study period
- •13. Signed informed consent prior to beginning protocol specific procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Platinum-sensitive patients (Group 2) who responded (CR or PR) to a 1st line therapy and subsequently progressed or relapsed after a treatment-free interval of > 12 months; treatment-free interval is defined as: time elapsing from the last day of 1st line therapy to the first day of second-line therapy start
- •2. Past or concurrent history of neoplasm other than ovarian adenocarcinoma, except
- •curatively treated non melanoma skin cancer or in situ carcinoma of the cervix
- •3. Pregnant or lactating patients
- •4. More than one line of chemotherapy for advanced metastatic ovarian cancer
- •5. Prior treatment with camptothecins
- •6. Presence or history of CNS metastasis or carcinomatous leptomeningitis
- •7. Current active infection per investigator assessment
- •8. Unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or
- •ulcerative colitis
- •9. Current history of chronic diarrhea = grade 1 (CTCAE version 3)
- •10. Surgery or radiotherapy = 4 weeks before first study treatment. In case of cytoreductive surgery for the progression of the disease, = 2 weeks before the 1st study treatment are allowed
- •11. Other uncontrolled, serious illness or medical condition, as determined by the
- •investigator
- •12. Concomitant (or within 4 weeks before inclusion) administration of any other
- •experimental drug under investigation
- •13. Concurrent treatment with any other anti-cancer therapy
- •14. Known HIV positivity or AIDS-related illness
- •15. Patients who cannot be regularly followed up for psychological, social, familial or
- •geographic reasons.
研究者
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