TIvantinib as Maintenance treatment in Extended Small-cell lung cancer (TIMES) Phase II clinical trial, single arm, two stage - TIMES

Istituto Oncologico del Veneto IRCCS – UOC Oncologia Medica 20 个研究点目标入组 66 人开始时间: 2014年10月13日最近更新: 2022年3月14日

适应症

试验速览

暂无简介。

•Age = 18 years.
•Histologically confirmed extensive-stage SCLC
•Disease control after the first line platinum/etoposide treatment
•ECOG performance status of 0 or 1
•Measurable disease according to RECIST Version 1.1 criteria
•Adequate bone marrow, liver, and renal function.
•Formalin Fixed Paraffin Embedded (FFPE) or frozen tumor tissue material must be available.
•Resolution of any toxic effects of prior therapy (including radiotherapy) according to NCI CTCAE, version 4.0, = Grade 1 (except for alopecia).
•Full recovery from significant complications of the surgery.
•If childbearing age, use of double-barrier contraceptive measures, oral or abstaining from sexual intercourse during the study and up to 90 days after the last dose of chemotherapy
•Negative pregnancy test within 72 hours prior to the initiation of study treatment, if of childbearing potential
•Signed informed consent prior to beginning protocol specific procedures
•Patients must be available for treatment and follow-up
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 33
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 33

•Clinically unstable central nervous system metastases
•Previous therapies with Tivantinib or other known c-MET inhibitor
•Radiotherapy for target lesions and major surgical procedure within 4 weeks, prior to the inclusion in the study
•Palliative radiotherapy within 2 weeks prior to the inclusion in the study
•History of malignancy in the past five years, excluding basal cell carcinoma of the skin, adequately treated intraepithelial carcinoma of the cervix, prostate cancer with a value of prostate-specific antigen <0.2 ng / mL
•History of cardiac disease
•Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infections
•Pregnant or lactating women or childbearing/reproductive potential not using adequate contraception
•Need for breastfeeding during or within 12 weeks of completion of the study
•Gastrointestinal disorders that may interfere with the absorption of Tivantinib
•Inability or unwillingness to swallow the complete doses of Tivantinib
•Any known contraindication to treatment and other significant co-morbid conditions which could jeopardize participation in the study

发起方

Istituto Oncologico del Veneto IRCCS – UOC Oncologia Medica 2