EUCTR2005-001680-57-AT进行中（未招募）不适用
Phase II study of fosfluridine tidoxil in an oral multiple dose schedule given once-a-day for 7 consecutive days every 2 weeks in patients with advanced breast and colorectal cancer
Heidelberg Pharma GmbH0 个研究点目标入组 80 人开始时间: 2005年8月18日最近更新:
试验速览
- 阶段
- 不适用
- 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
- All
入选标准
- •- Patients with histologically or cytologically confirmed metastatic breast or colorectal cancer.
- •- At least one measurable lesion, as identified within the 4-week period prior to Screening (Visit 1 [Day -3 to -1]), which has not previously been irradiated.
- •Minimum measurable lesion size, in accordance with the RECIST criteria as measured at Screening (Visit 1 [Day -3 to -1]) or within the prior 4-week period :>= 10 mm measured by spiral computed tomography (CT) scan, or >= 20 mm measured by conventional CT scan.
- •- Male or female patients aged 18 years or older.
- •- Predicted life expectancy of >= 12 weeks as determined at Screening (Visit 1 [Day -3 to -1]), allowing adequate follow-up evaluation for toxicity and tumour response.
- •- Performance status of <= 2 on the ECOG scale
- •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
- •- Patients who received radiotherapy of one or more of the target lesions, within the 4 -week period prior to Screening (Visit 1 [Day 3 to -1]).
- •- Patients who are scheduled to receive planned radiotherapy during the planned Treatment Period or during follow-up.
- •- Patients who received more than 2 cycles of a 5-FU-containing combination chemotherapy in the treatment of metastatic colorectal cancer.
- •- Patients who have received 5-fluoropyrimidine-containing adjuvant treatment for colorectal cancer that was completed less than 12 months prior to Screening (Visit 1 [Day -3 to -1]).
- •- Patients who received more than two lines chemotherapy containing taxanes and/or anthracyclines in the treatment of metastatic breast cancer.
- •- Patients who have received neoadjuvant or adjuvant treatment for breast cancer that was completed less than 12 months prior to Screening (Visit 1 [Day -3 to -1]).
- •- Patients who received major surgery within the 4-week period prior to the first administration of study drug (Cycle 1 [Day 1]).
- •- Patients who received major surgery more than 4 weeks prior to the first administration of study drug (Cycle 1 [Day 1]), but who did not completely recover after surgery.
- •- Patients who received minor surgery within the 2-week period prior to the first administration of study drug (Cycle 1 [Day 1]).
- •- Patients who received radiotherapy or chemotherapy within the 4-week period prior to the first administration of study drug (Cycle 1 [Day 1]).
- •- Patients who received autologeous or allogeneic bone marrow transplantation at any time prior to Screening (Visit 1 [Day -3 to -1]).
- •Patients with known brain or meningeal metastases as determined at Screening (Visit 1 [Day -3 to -1]).
研究者
相似试验
招募中
3 期
Evaluation of the Effect of Oral fosfomycin Addition on Treatment of Patients with Klebsiella pneumoniae Carbapnemase Infections with ColistiIRCT20191104045328N1Arak University of Medical Sciences62
进行中（未招募）
不适用
Phase II Multiple-Dose Clinical Trial of Oral ITF 2357 In Patients with Advanced Multiple Myelomamultiple myelomaMedDRA version: 6.1Level: PTClassification code 10028228EUCTR2005-001084-56-ITITALFARMACO34
已完成
不适用
Phase II study of first-line treatment by FOLFOXIRI+bevacizumab in patients with RAS mutant-type metastatic colorectal cancerColorectal CancerJPRN-UMIN000015152onprofit Organization Japan Clinical Cancer Research Organization60
已完成
不适用
The effects of peroral administration of Tofogliflozin(SGLT2 inhibitor) on endogenous glucose production and insulin clearance, single effet and chronic effect.JPRN-UMIN000031686niversity of Juntendo12
已完成
不适用
The effect of the intra oral slow release fluoride device in remineralisation of enamel and dentine in situ.Dental cariesISRCTN21720818Department of Health25