NL-OMON50657已完成不适用
A phase I dose finding study of oral LXH254 in adult patients with advanced solid tumors harboring MAPK pathway alterations. - CLXH254X2101
ovartis Pharma BV0 个研究点目标入组 20 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
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
- •** 18 years old.
- •*Progressed following standard therapy, or, in the opinion of the Investigator,
- •no effective standard therapy exists, is tolerated or appropriate.
- •*Dose escalation part: Advanced solid tumors, harboring at least one MAPK
- •pathway alteration (see protocol Table 5-1) when enrolled in cohorts testing
- •LXH254 single agent or NSCLC patients and NRAS mutant melanoma patients with
- •specific mutations in the MAPK pathways for cohorts testing LXH254 in
- •combination with PDR001.
- •*Dose expansion part: other advanced solid tumors harboring documented MAPK
- •pathway alteration (protocol Table 5-1). These include but are not limited to:
- •-Confirmed KRAS and/or BRAF-mutated NSCLC.
- •-Confirmed KRAS and/or BRAF-mutated ovarian cancer.
- •-BRAF V600-mutated melanoma patients who are refractory to or relapsed on
- •prior BRAFi/MEKi combination therapy, NRAS-mutated melanoma
- •LXH254 in combination with PDR001: NSCLC patients with specific mutations in
- •the MAPK pathway and patients with NRAS mutated melanoma
- •-NRAS- mutated solid tumors,
- •*ECOG performance status 0-1
排除标准
- •*Prior treatment with a BRAF, MEK and/or pan-RAF inhibitor in patients with
- •confirmed KRAS and/or BRAF-mutated NSCLC and ovarian cancer in dose expansion
- •*Prior treatment with any of the following (see protocol page 37 for details
- •incl. time frames): radiation, chemotherapy, cytotoxic agents with major
- •delayed toxicities, major surgery, immunotherapy.
- •*History or current evidence of retinal vein occlusion (RVO) or current risk
- •factors for RVO.
- •*Gilbert*s syndrome or other heritable diseases of bile processing.
- •*Clinically significant cardiac disease, see protocol page 38 for details.
- •*Out of range laboratory values. See protocol page 38-39 for details.
- •*Sexually active males unless they use a condom during intercourse.
- •*Pregnancy, lactation, insufficient contraception for females of childbearing
研究者
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