EUCTR2005-005168-94-DE进行中（未招募）不适用
Multicenter Phase II- trial to investigate safety and efficacy of an Adjuvant Therapy with Gemcitabine and Erbitux® in patients with R0 or R1 resected Pancreatic cancer - ATIP
Philipps-University of Marburg0 个研究点目标入组 73 人开始时间: 2006年1月31日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 73
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
- •Provided signed written informed consent.
- •Men and woman age >= 18 years
- •Histologically confirmed R0 or R1 resected ductal adenocarcinoma of the pancreas
- •Life expectancy >12 weeks
- •Patients with ECOG performance status <= 2
- •Patients without metastasis
- •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 76
排除标准
- •Women of child bearing potential (WOCP) who are unwilling or unable to use an
- •acceptable method to avoid pregnancy for the entire study period and follow-up
- •to 4 weeks after the study.
- •Women who are pregnant or breastfeeding.
- •Women with a positive pregnancy test on enrolment or prior to study drug
- •administration.
- •Dementia, altered mental status, or any psychiatric condition that would prohibit
- •the understanding or rendering of informed consent.
- •Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in
- •situ of the cervix. (Patients with a previous malignancy but without evidence of
- •disease for > 5 years will be allowed to enter the trial).
- •Inadequate hematologic function defined by an absolute neutrophils count (ANC)
- •< 1,500/mm³, a platelet count < 100,000/mm³ and a hemoglobin < 9 g/dL.
- •Inadequate hepatic function defined by the upper limit of normal (ULN), AST and
- •ALT levels > 5 times the ULN.
- •Serum bilirubine > 1.5 times the ULN.
- •Inadequate renal function defined by a serum creatinine > 1.5 times the ULN.
- •Prior cetuximab or other therapy which targets the EGF pathway.
- •Prior antibody therapy.
- •Any known allergic reaction against cetuximab.
- •Any concurrent chronic systemic immune therapy, radiation therapy, hormonal
- •therapy (except for physiological replacement), or any other investigational
- •HIV infection.
- •Having participated in another clinical trial in the preceding 30 days.
研究者
相似试验
进行中（未招募）
2 期
Prospective trial to evaluate the safety and efficacy to treat esophageal cancer using 5-FU, Oxaliplatin, and DocetaxelJPRN-jRCTs031200094Kawakubo Hirofumi60
进行中（未招募）
1 期
Safety and tolerability of BAY63-2521 in Cystic Fibrosis patientsMedDRA version: 19.0Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersCystic FibrosisEUCTR2013-004595-35-BEBayer AG63
进行中（未招募）
1 期
Safety and tolerability of BAY63-2521 in Cystic Fibrosis patientsMedDRA version: 19.1Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersCystic FibrosisEUCTR2013-004595-35-GBBayer AG63
进行中（未招募）
1 期
Safety and tolerability of BAY63-2521 in Cystic Fibrosis patientsCystic FibrosisEUCTR2013-004595-35-DEBayer AG63
已完成
2 期
A phase 2 multicenter study evaluating the safety and efficacy of Nilotinib in patients with Imatinib-resistant/intolerant Ph+CML in chronic phaseChronic myelogenous leukemiaJPRN-UMIN000002007Shimousa Hematology Study Group40