A Phase I Study of Merestinib Monotherapy or in Combination With Other Anti-Cancer Agents in Japanese Patients With Advanced and/or Metastatic Cancer

Eli Lilly Japan K.K.0 个研究点目标入组 18 人开始时间: 2017年2月13日最近更新: 2023年10月17日

试验速览

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•Part A: Histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic (solid tumors or non-Hodgkin's lymphoma).
•-Part B: Biliary tract carcinoma that is unresectable, recurrent, or metastatic. The participant must not have received prior systemic front-line therapy for metastatic or resectable disease.
•-Part A: Measurable or nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Cheson Criteria.
•-Part B: Measurable disease as defined by RECIST v1.1.
•-Adequate organ function including hematologic, hepatic and renal.
•-Eastern Cooperative Oncology Group (ECOG) scale of 0 or 1.
•-Are able to swallow tablets.
•-Part B: A tumor tissue sample is mandatory for biomarker analysis.
•-Males must agree to use medically approved barrier contraceptive precautions during the study and for 3 months following the last dose of study drug.
•-Females with childbearing potential: Must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of study drug, must have had a negative serum or urine pregnancy test less than or equal to 7 days before the first dose of study drug.
•-A breastfeeding woman must not be breastfeeding. If a female who stops breastfeeding enters the study, breastfeeding must cease from the day of the first study drug administration until at least 3 months after the last administration.

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