Selecting cancer patients for treatment using Tumor Organoids, the SENSOR study - SENSOR

Antoni van Leeuwenhoek - Netherlands Cancer Institute0 sites70 target enrollmentMarch 23, 2016

Overview

No summary available.

Registry

who.int

Start Date

March 23, 2016

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Antoni van Leeuwenhoek - Netherlands Cancer Institute

•1\.Patients with locally advanced (incurable) or metastatic colorectal cancer or NSCLC that have only one line standard of care treatment left, or will start with a study treatment. Patients should have received a first line standard of care treatment.
•2\.Patients for whom treatment with curative intent is not an option
•3\.RECIST 1\.1 evaluable metastatic or locally advanced lesion(s).
•4\.Metastatic or locally advanced lesion(s) of which a histological biopsy can safely be obtained
•5\.Adequate kidney and liver function.
•6\. WHO performance status 0\-1
•7\. Informed consent
•8\. 18 years or older
•Additional in\- and exclusion criteria are provided for each experimental compound
•Are the trial subjects under 18? no

•1\.Pregnant or lactating (nursing) women
•2\.Prior malignancy within 5 years. Patients with a history of non\-melanomatous skin cancer, successfully treated carcinoma in situ or with a disease free period of \> 5 years may be included.
•3\.Known infection with human immunodeficiency virus (HIV).
•4\.Leptomeningeal carcinomatosis.
•5\.Symptomatic brain metastasis. Patients that are asymptomatic and have been stable for 3 months (confirmed by MRI/CT scan) are eligible for participation if they are not receiving corticosteroid therapy or anti\-epileptic drugs.
•6\.Other psychiatric or medical conditions that would make the patient unfit for participation due to an increase in the risk associated with study participation or incompliance with study procedures.
•7\.Life expectancy of less than 3 months from tumor progression under standard of care.
•Additional in\- and exclusion criteria are provided for each experimental compound