RecruitingPhase 2Phase 3NCT03458221

Signal TrAnsduction Pathway Activity Analysis in OVarian cancER


Sponsor

Gynaecologisch Oncologisch Centrum Zuid

Enrollment

148 participants

Start Date

Jan 31, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is analyzing tumor tissue from women with recurrent ovarian cancer to identify which biological pathways are driving each individual's cancer, with the goal of matching patients to targeted treatments that may work better for them personally. **You may be eligible if...** - You are a woman over 18 with ovarian cancer that has come back after treatment - Your cancer did not respond to platinum-based chemotherapy (returned within 6 months), or you have chosen not to pursue standard chemotherapy - Your CA125 tumor marker has been rising on two blood tests taken at least 28 days apart - You are willing to have a tumor biopsy taken - You speak and understand Dutch - You are in reasonably good overall health (able to care for yourself) **You may NOT be eligible if...** - You are currently receiving any other cancer treatment - You have never received chemotherapy before - You had a second primary cancer (other than non-melanoma skin cancer) within the past year - You are pregnant or breastfeeding - You are participating in another treatment clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLetrozole Oral Product

Letrozole 2.5mg tablet - 2.5mg once dailty until progression of disease.

DRUGBicalutamide Oral Product

Bicalutatmide 150mg tablet - 150mg once daily until progression of disease.

DRUGEverolimus Oral Product

Everolimus 10mg tablet - 10mg once daily until progression of disease.

DRUGItraconazole Oral Product

Itraconazole 100mg capsule - 300mg twice daily until progression of disease.


Locations(6)

Radboudumc

Nijmegen, Gelderland, Netherlands

Catharina Ziekenhuis

Eindhoven, North Brabant, Netherlands

Amphia Hospital

Breda, Netherlands

Maastricht UMC+

Maastricht, Netherlands

Erasmus MC

Rotterdam, Netherlands

Elisabeth-Tweesteden Hospital

Tilburg, Netherlands

View Full Details on ClinicalTrials.gov

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NCT03458221


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