NL-OMON45070招募中不适用
A phase Ib/II multi-center, open label, dose escalation study of WNT974, LGX818 and cetuximab in patients with BRAFV600-mutant KRAS wild-type metastatic colorectal cancer harboring Wnt pathway mutations - CWNT974X2102C
Array Biopharma0 个研究点目标入组 4 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •Histological or cytological confirmed metastatic colorectal cancer.
- •Written documentation of KRAS-wild-type status and BRAFV600 mutation with RNF43 mutations and/or RSPO fusions. See protocol page 37 for details.
- •Progression of disease after at least one prior standard of care regimen or intolerance to irinotecan based regimens. See protocol page 37 for details.
- •Measurable disease.
- •ECOG performance status 0, 1, 2.
排除标准
- •Phase II only: Prior treatment with RAF inhibitors, Wnt pathway inhibitors, cetuximab, panitumumab, and/or other EGFR inhibitors.
- •Symptomatic brain metastasis. See protocol page 38 for details.
- •Use of strong inhibitors or inducers of CYP3A4/5 or herbal medications. See protocol page 38 for details.
- •Acute and chronic pancreatitis, clinically significant cardiac disease. See protocol page 38 for details.
- •History of thromboembolic or cerebrovascular events within the last 6 months.
- •Radiation therapy that includes >30% of the bone marrow reserve, chemotherapy, biological therapy (e.g., antibodies) within <= 4 weeks (6 weeks for nitrosourea, mitomycin-C), or who have been treated with continuous or intermittent small molecule therapeutics or investigational agents within 5 half-lives of the agent.
- •Pregnancy, lactation, inadequate contraception (males and females). See protocol page 39 for details.
研究者
相似试验
进行中(未招募)
不适用
Study of WNT974 in combination with LGX818 and cetuximab in patients with BRAF-mutant metastatic colorectal cancer (mCRC) and Wnt pathway mutationsMedDRA version: 19.0Level: HLTClassification code 10010023Term: Colorectal neoplasms malignantSystem Organ Class: 100000004864colorectal cancerEUCTR2014-002826-11-FRArray BioPharma Inc.55
进行中(未招募)
1 期
Study of WNT974 in combination with LGX818 and cetuximab in patients with BRAF-mutant metastatic colorectal cancer (mCRC) and Wnt pathway mutationsMedDRA version: 20.0 Level: HLT Classification code 10010023 Term: Colorectal neoplasms malignant System Organ Class: 100000004864colorectal cancerEUCTR2014-002826-11-ESArray BioPharma Inc.20
进行中(未招募)
1 期
Study of WNT974 in combination with LGX818 and cetuximab in patients with BRAF-mutant metastatic colorectal cancer (mCRC) and Wnt pathway mutationscolorectal cancerMedDRA version: 20.0Level: HLTClassification code 10010023Term: Colorectal neoplasms malignantSystem Organ Class: 100000004864EUCTR2014-002826-11-NLArray BioPharma Inc.55
进行中(未招募)
1 期
Study of WNT974 in combination with LGX818 and cetuximab in patients with BRAF-mutant metastatic colorectal cancer (mCRC) and Wnt pathway mutationsMedDRA version: 20.0Level: HLTClassification code 10010023Term: Colorectal neoplasms malignantSystem Organ Class: 100000005080colorectal cancerEUCTR2014-002826-11-BEArray BioPharma Inc.55
进行中(未招募)
1 期
Study of LGX818 and cetuximab or LGX818, BYL719, and cetuximab in BRAF mutant metastatic colorectal cancerBRAF mutant metastatic colorectal cancerMedDRA version: 18.1 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-002138-35-BEArray BioPharma Inc.162
