Signal TrAnsduction Pathway activity analysis for OVarian cancER treatment. STAPOVER study - STAPOVER study

Stichting Catharina Hospital0 个研究点目标入组 146 人开始时间: 2021年5月18日最近更新: 2021年9月13日

适应症

试验速览

暂无简介。

•-Age > 18 years.
•-Patients with recurrent ovarian cancer who meet one of the following criteria:
•oPlatinum-resistant disease or;
•oPatients refrains from standard therapy or;
•oAsymptomatic patients who are not yet eligible for standard palliative chemotherapy but have an increase of CA125 tumour marker at two consecutive timepoints 28 days apart with a value of two times nadir above 35 U/ml).
•-Progressive disease after at least one prior line of systemic treatment for recurrent disease.
•-Radiologically evaluable disease according to RECIST 1.1 criteria.
•-Ability and willingness to obtain a tumour biopsy after the last course of standard treatment and before start of the study.
•-Ability and willingness to provide written and oral consent.
•-Able to speak and understand the Dutch language.
•-WHO performance status 0-II.
•-Adequate renal and liver function to start matched targeted therapy (according to the local clinician).
•-Adequate use of contraceptives in case of patients with childbearing potential.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 115

•-Age < 18 years.
•-Patient is receiving any other anti-cancer therapy (e.g. cytotoxic or targeted drug or radiation) or is chemotherapy naïve. The required wash out period prior to start of matched targeted therapy is at least three weeks.
•-Patient is diagnosed with or treated for a second primary tumour (except non-melanoma skin tumour) one year prior to study inclusion.
•-Inability to obtain (sufficient) tumour material.
•-Previous use of the selected targeted drug as anti-cancer agent.
•-Physical condition WHO III-IV.
•-Pregnant or lactating women.
•-Simultaneous participation in another treatment-related clinical trial.
•-Patients with any other clinically significant medical condition which, in the opinion of the local clinician, makes it undesirable for the patient to participate in this study or which could jeopardize compliance with study requirements including, but not limited to: ongoing or active infection, severe psychiatric illness, or complicated social situations.

发起方

Stichting Catharina Hospital