Signal TrAnsduction Pathway Activity Analysis in OVarian cancER

STAPOVER

The purpose of this prospective, parallel-group, cohort study is to implement phenotype-guided targeted therapy based on functional signal transduction pathway (STP) activity in recurrent ovarian cancer patients using a novel mRNA-based assay. Existing targeted drugs with tolerable toxicity profiles are used to investigate the therapeutic value beyond their approved indication, which are deemed beneficial in the select group of patients with a relevant predominantly active functional STP, in order to improve survival and maintain quality of life.

2023-01-31

2026-10-01

2026-10-01

Recruiting

Early phase I

148

Inclusion Criteria: * Female, age \> 18 years * Patients with recurrent ovarian cancer who meet one of the following criteria: * Platinum-resistant disease, defined as disease recurrence or progression within six months of last platinum-based chemotherapy or; * Patient refrains from standard therapy or; * Asymptomatic patient who is not yet eligible for standard palliative chemotherapy but has an increase of CA125 tumour marker at two consecutive time points 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 (36). * 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. Exclusion Criteria: * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Targeted therapy based on functional signal transduction pathway activation in patients with recurrent ovarian cancer.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 148, 'type': 'ESTIMATED'}}

2023-04-18