EUCTR2004-000753-30-ES进行中（未招募）1 期
Phase II trial of oral vinorelbine in combination with capecitabine as first line therapy in women with previously untreated HER2 negative metastatic breast cancer. - Not applicable
Pierre Fabre Ibérica S.A. as legal representative of Pierr Fabre Mèdicament0 个研究点目标入组 55 人开始时间: 2004年10月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 55
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
入选标准
- •Women with age not less than 18 years,
- •Documented metastatic breast cancer previously untreated by chemotherapy,
- •HER2 negative (assessed by 0-1 + IHC or 2+ IHC with FISH-) on the primary tumor or on metastatic site,
- •At least one measurable lesion using the RECIST criteria,
- •Karnofsky Performance Status not less than 70%,
- •Life expectancy not less than 16 weeks,
- •Adequate bone marrow, hepatic and renal functions.
- •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
- •Local relapse alone after conservative treatment of contra-lateral tumor,
- •Pregnant or lactating women,
- •Patient with syptoms suggesting CNS involvment or leptomeningeal metastases,
- •Concomitant hormone therapy for metastaticbreast cancer,
- •Malabsorption syndrome or disease significantly affecting gastro-intestinal function or major resection of the stomach or proximal small bowel that could affect absorption of capecitabine (Xeloda) and oral vinorelbine (Navelbine Oral),
- •Other serious illness or medical conditions.
研究者
相似试验
进行中（未招募）
1 期
Phase II trial of oral vinorelbine in combination with capecitabine and trastuzumab as first line therapy in women with previously untreated HER2 positive metastatic breast cancer. - Not applicableEUCTR2004-000748-26-ESPierre Fabre Ibérica, S.A. en representación de Pierre Fabre Mèdicament55
进行中（未招募）
1 期
Study to assess the efficacy and safety of oral vinorelbine in combination with capecitabine in patients suffering from breast cancer previously treated with other chemotherapies (anthracyclines, and taxanes)EUCTR2004-000665-35-ESPierre Fabre Medicament
进行中（未招募）
1 期
Randomised phase II trial to compare two first line chemotherapy regimen : oral vinorelbine and cisplatin followed by maintenance therapy with single agent oral vinorelbine and gemcitabine and cisplatin followed by maintenance therapy with single agent gemcitabine in Locally Advanced or Metastatic Non-Small-Cell Lung Cancer patients with squamous histological type.First line locally advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) patient with squamous histological type.MedDRA version: 14.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-003531-40-ITPIERRE FABRE MEDICAMENT110
进行中（未招募）
1 期
Study evaluating oral vinorelbine and cisplatin followed by oral vinorelbine alone versus gemcitabine and cisplatin followed by gemcitabine alone in patients with a specific type of lung cancerFirst line Locally Advanced or Metastatic Non-Small-Cell Lung Cancer patients with squamous histological typeMedDRA version: 15.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-003531-40-ATPierre Fabre Medicament113
进行中（未招募）
1 期
Study evaluating oral vinorelbine and cisplatin followed by oral vinorelbine alone versus gemcitabine and cisplatin followed by gemcitabine alone in patients with a specific type of lung cancerFirst line Locally Advanced or Metastatic Non-Small-Cell Lung Cancer patients with squamous histological typeMedDRA version: 19.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-003531-40-PLPierre Fabre Medicament110