EUCTR2007-003323-20-BE进行中（未招募）不适用
A Phase I/II Study of CP-4055 in Patients with Platinum Resistant Ovarian Cancer - CP4055-204
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- All
入选标准
- •1. Histologically or cytologically documented advanced (stage III and IV according to the FIGO and AJCC systems) epithelial ovarian cancer measurable with CT and/or MRI, excluding mixed mullerian tumours (MMT) (carcinosarcomas)
- •2. Received prior chemotherapy regimen(s) for ovarian cancer, at least one being a platinum based therapy (PBT); i.e., carboplatin, cisplatin, or another organoplatinum compound. The last dose of prior chemotherapy should have been given at least 6 weeks before start of CP-4055 treatment
- •3. Evidence of platinum resistant or refractory disease. Resistant defined as progression according to RECIST or CA-125 within 6 months after completion of PBT. Refractory defined as progression during PBT or no disease free period during PBT. See Appendix B1 and Appendix B2
- •4. ECOG Performance Status 0 – 1
- •5. Age 18 years or more
- •6. Life expectancy > 3 months
- •7. Signed informed consent (IC)
- •8. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this study. Nursing patients are excluded.
- •9. Women of child-bearing potential must not become pregnant while participating in the study
- •10. Adequate haematological and biological functions:
- •Bone marrow function:
- •a.Neutrophils = 1.5 x 10 in 9 /L
- •b.Platelets = 100 x 10 in 9 /L
- •c.Hb = 9 g/dL
- •Hepatic function:
- •a.AST (SGOT) / ALT (SGPT) = 2.5 times institutional upper limit of normal (ULN). If liver metastases = 5 times institutional ULN
- •b.Serum bilirubin = 1.5 times institutional ULN
- •Renal function:
- •Creatinine = 1.5 times institutional ULN
- •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. Patients with mixed mullerian tumours (MMT) (carcinosarcomas)
- •2. Known brain metastases
- •3. Another known active cancer within the last 5 years
- •4. Radiotherapy to more than 30 % of bone marrow
- •5. Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
- •6. Concomitant treatment with a non-permitted medication:
- •Alternative medicine, i.e., any of various systems of healing or treating disease (such as non-prescriptive drugs, herbal medicine, homeopathy)
- •High doses of vitamins
- •7. 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
- •8. Any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection)
- •9. Any significant central nervous system or psychiatric disorder(s) that would hamper the patient’s compliance
- •10. Pregnancy or breastfeeding
- •11. Known positive status for HIV and/or hepatitis B or C
- •12. Drug and/or alcohol abuse
- •13. Any reason why, in the investigator’s opinion, the patient should not participate
研究者
相似试验
进行中（未招募）
不适用
A phase II Clinical Study of CP-4055 in patients with metastatic melanoma not previous treated with chemotherapy - CP4055-201A phase II clinical study of CP-4055 in patients with metastatic melanoma not previous treated with chemotherapyEUCTR2005-000690-22-SEClavis Pharma as42
进行中（未招募）
不适用
A Phase I/II Study of CP-4055 in Patients with Refractory/Relapsed Hematologic MalignanciesEUCTR2006-000868-83-GBClavis Pharma ASA200
进行中（未招募）
不适用
A Phase I/II Study of CP-4055 in Patients with Refractory/Relapsed Hematologic MalignanciesEUCTR2006-000868-83-DEClavis Pharma ASA200
已完成
1 期
A Phase I/II Study of CP-4055 in Patients With Platinum Resistant Ovarian CancerOvarian CancerNCT00831636Clavis Pharma28
进行中（未招募）
1 期
A phase II Clinical Study of CP-4055 as second line therapy in patients with advanced colorectal cancer - CP4055-202A phase II clinical study of ELACYT as second line therapy in patients with advanced colorectal cancerEUCTR2006-006766-41-GBClavis Pharma ASA42