A phase I dose finding study of oral LTT462 in adult patients with advanced solid tumors harboring MAPK pathway alterations

ovartis Pharma Services AG0 个研究点目标入组 65 人开始时间: 2016年10月11日最近更新: 2019年6月30日

试验速览

暂无简介。

•- Patient (male or female) =12 years of age
•- ECOG (Eastern Cooperative Oncology Group) performance status =1
•- Must have progressed following standard therapy, or for whom, in the opinion of the Investigator, no effective standard therapy exists, is tolerated or appropriate.
•- Patients must have a site of disease amenable to biopsy and be a candidate for tumor biopsy. Patients must be willing to undergo a new tumor biopsy at screening/baseline and during therapy.
•- Presence of at least one measurable lesion according to RECIST v1.1.
•- Documented MAPK Pathway alteration.
•Other protocol-defined inclusion criteria may apply.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 2
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 55
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 24

•- Prior treatment with ERK inhibitors.
•- History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.
•- Any medical condition that would, in the investigator’s judgment, prevent the patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures.
•- Patients receiving proton pump inhibitors (PPI) which cannot be discontinued 3 days prior to the start of study treatment and for the duration of the study.
•- Clinically significant cardiac disease.
•Other protocol-defined exclusion criteria may apply.

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