ACTRN12607000589482招募中3 期
Phase III randomised study of Brivanib Alaninate (BMS-582664) in combination with Cetuximab (Erbitux 'Registered trade mark') versus placebo in combination with Cetuximab (Erbitux 'Registered trade mark') in patients with K-Ras wild type tumours previously treated with combination chemotherapy for metastatic colorectal carcinoma to compare overall survival.
Australasian Gastro-Intestinal Trials Group (AGITG)0 个研究点目标入组 750 人开始时间: 2007年11月16日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 750
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Age > 18 years Histologically confirmed metastatic colorectal cancer Confirmed K-Ras wild type tumour Previously treated with thymidylate synthase inhibitor Previously failed treatment with irinotecan-containing regimen and oxaliplatin-containing regimen where failure is defined as either progression of disease or intolerance to the regimen due to severe allergic reaction or delayed recovery from toxicity. Measurable or evaluable disease Minimum 4 weeks have elapsed since recent surgery, chemotherapy, treatment with another investigational agent, or radiation therapy ECOG performace status of 0, 1, or 2 Provision of blood/tumor speciments for correlative studies
排除标准
- •K-Ras mutant, indeterminate, or no tumour tissue available for testing History of other malignancies other than non-melanoma skin cancer, in-situ cancer of the cervix, or other curatively treated solid tumors with no evidence of disease for > 5 years Any active disease condition which would render protocol treatment dangerous or does not permit compliance with protocol Uncontrolled or significant cardiovascular disease, hypertension, or a history of thromboembolic event in last 6 months Central nervous system metastases Prior treatment with Cetuximab or other EGFR (epidermal growth factor receptor) pathway targetting agent or murine monoclonal antibody
研究者
相似试验
进行中（未招募）
不适用
A Blinded, Randomized, Phase 1/2 Study of Brivanib Alaninate vs. Placebo in Combination with Erbitux and Irinotecan in K-Ras wild type Subjects with Metastatic Colorectal Cancer. Revised Protocol 06 incorporating Protocol Amendment 09.+ Pharmacogenetics Blood Sample Amendment 01+ Amendment Number 05 - Site Specific (version 1.0, dated 11-Aug-08)EUCTR2007-005097-31-DKBristol Myers Squibb International Corporation133
进行中（未招募）
不适用
A Blinded, Randomized, Phase 1/2 Study of Brivanib Alaninate vs. Placebo in Combination with Erbitux and Irinotecan in K-Ras wild type Subjects with Metastatic Colorectal Cancer. Revised Protocol 06 incorporating Protocol Amendment 09; And Pharmacogenetics Blood Sample Amendment 01.Patients with advanced metastatic colorectal cancer (MCRC)MedDRA version: 9.1Level: LLTClassification code 10061451Term: Colorectal cancerEUCTR2007-005097-31-SEBristol Myers Squibb International Corporation133
进行中（未招募）
1 期
A Blinded, Randomized, Phase 1/2 Study of Brivanib Alaninate vs. Placebo in Combination with Erbitux and Irinotecan in K-Ras wild type Subjects with Metastatic Colorectal Cancer. Revised Protocol 03 (v5.0, dated 2 July 2008) incorporating Protocol Amendment 04 (v1.0, dated 2 July 2008). And Pharmacogenetics Blood Sample Amendment 01.Estudio fase 1/2, enmascarado y aleatorizado de brivanib alaninato frente a placebo en combinación con Erbitux e Irinotecán en sujetos con cáncer colorrectal metastásico con K-Ras de tipo natural.Protocolo revisado 03 (v5.0, 02-Julio-08) incorporando la enmienda al protocolo 04(v1.0, 2 -Julio- 2008) y enmienda 01 de muestra de sangre para farmacogénética.Patients with advanced metastatic colorectal cancer (MCRC)Pacientes con cáncer colorrectal metastásico avanzadoMedDRA version: 9.1Level: LLTClassification code 10061451Term: Colorectal cancerEUCTR2007-005097-31-ESBristol Myers Squibb International Corporation133
已完成
1 期
Ascending Multiple-Dose Study of Brivanib Alaninate in Combination With Chemotherapeutic Agents in Subjects With Advanced CancersAdvanced CancerNCT00798252Bristol-Myers Squibb111
已完成
1 期
Phase I/II Combination With Irinotecan- ErbituxMetastatic Colorectal Cancer (MCRC)NCT00594984Bristol-Myers Squibb38