Drug-drug interactions study of TAS-115 with pioglitazone, losartan, and midazolam in patients with solid tumors

Motoo Yoshiharu0 个研究点目标入组 18 人开始时间: 2021年10月11日最近更新: 2024年5月27日

试验速览

暂无简介。

•(1) Provided written informed consent
•(2) Aged 20 or older at the time of consent (If Malignant bone tumor, aged 15 or older at the time of consent)
•(3) Has a histologically or cytologically confirmed diagnosis of solid tumor
•(4) Patients who did not respond to or cannot tolerate the standard treatment or the similar treatment or for whom no appropriate therapy is available
•(5) Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 before administration of study treatment
•(6) Has adequate organ function as defined by the following criteria
•a. ANC >= 1500 /mm3 (excluding measurements obtained within 7 days after administration of granulocyte colony-stimulating factor [G-CSF])
•b. Hemoglobin value of >= 8.0 g/dL excluding measurements within 4 weeks after a transfusion of packed red blood cells or whole blood
•c. Platelet count >= 75000 /mm3 (excluding measurements obtained within 3 days after a transfusion of platelets)
•d. AST and ALT =< 3 x ULN
•e. T-Bil of =< 1.5 x ULN
•f. Caluculated Creatinine Clearance =< 50 mL/min
•(7) Has a life expectancy of at least 90 days

•(1) Having a history of the following treatments;
•a. History of extensive surgery requiring general anesthesia within 4 weeks before enrollment (it should be confirmed that the surgical wound has been cured before enrollment) ;
•b. History of the use of any investigational drug or device within 4 weeks before enrollment;
•c. History of radiotherapy within 4 weeks before enrollment;
•d. History of anticancer therapy within 2 weeks before enrollment;
•e. History of bone marrow transplantation or stem cell transplantation (excluding autologous peripheral stem cell transplantation) ;
•f. History of administration of TAS-115;
•(2) Any ADR to prior therapy has not resolved to Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (excluding anemia, alopecia, skin hyperpigmentation, peripheral sensory neuropathy and hypertension);
•(3) Having diseases considered inappropriate for participation in this study;
•(4) Patients who are pregnant, possibly pregnant, or lactating, including if breastfeeding is interrupted.
•(5) Female patients of childbearing potential or male patients who do not agree to use appropriate contraception during the following period.
•- Women of childbearing potential: During the study period and for 7 months after the last administration.
•- Men: During the study period and for 4 months after the last administration.

发起方

Motoo Yoshiharu