Allocation of patients with pre-treated solid tumors to anti-cancer therapy based on gene expression drug response prediction - a phase II basket trial

Vejle Hospital0 个研究点目标入组 40 人开始时间: 2019年6月11日最近更新: 2020年7月27日

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•Histopathologically verified advanced, metastatic cancer (breast, ovarian, lung, prostate, colorectal, pancreatic) without curatively intended treatment options.
•Measurable disease according to RECIST 1.1, or GCIG CA125 criteria for ovarian cancer, or PCWG3 criteria for prostate cancer
•Performance status 0-1
•Age = least 18 years
•Adequate bone marrow, liver and renal function (within 7 days prior to inclusion)
•oNeutrophils (ANC) = 1.5x10^9/L
•oPlatelet count = 100x10^9/L
•oHemoglobin = 9.0 g/dL or = 5,6 mmol/L
•oSerum bilirubin = 2,0 x ULN
•oSerum alanine aminotransaminase = 2.5 x ULN
•oSerum creatinine = 1.5 x ULN (a creatinine above 1.5 x ULN measured or calculated GFR must be at least 50 mL/min.
•At least 2 previous chemotherapy regimens
•Written and orally informed consent
•Consent to translational research and biobank
•Eligible for chemotherapy according to investigator
•Life expectancy > 3 months
•Contraception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject’s male partner, and hormonal contraceptive are acceptable.
•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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 1 year before enrollment
•Active, serious infection, bleeding, or other serious disease
•Other active, malignant disease, except basocellular or squamous skin cancer and carcinoma in situ cervicis uteri
•Fertile women not willing to use effective methods of contraception during and 6 months after end of treatment
•Other systemic treatment or radiotherapy treatment within 28 days prior to treatment start
•Pregnancy or lactation

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