Letrozole Oral Product: Letrozole 2.5mg tablet - 2.5mg once dailty until progression of disease.
Bicalutamide Oral Product: Bicalutatmide 150mg tablet - 150mg once daily until progression of disease.
Everolimus Oral Product: Everolimus 10mg tablet - 10mg once daily until progression of disease.
Itraconazole Oral Product: Itraconazole 100mg capsule - 300mg twice daily until progression of disease.
Study 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
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Progression free survival on matched targeted therapy determined by STP-activity (PFS2) in comparison to the PFS recorded on the therapy administered immediately prior to enrolment (PFS1). — From baseline until the date of documented disease progression or 12 months after the start of targeted therapy. PFS on matched targeted therapy (PFS2) is defined as the time from start of matched targeted therapy to disease progression, defined by RECIST 1.1 criteria, or death from any cause. PFS on prior therapy (PFS1) is defined as the time from start of the prior treatment to disease progression defined by RECIST 1.1 criteria
Trial sites (6)
Facility
City
Region
Status
Radboudumc
Nijmegen
Gelderland
Not Yet Recruiting
Catharina Ziekenhuis
Eindhoven
North Brabant
Recruiting
Amphia Hospital
Breda
Netherlands
Not Yet Recruiting
Maastricht UMC+
Maastricht
Netherlands
Not Yet Recruiting
Erasmus MC
Rotterdam
Netherlands
Not Yet Recruiting
Elisabeth-Tweesteden Hospital
Tilburg
Netherlands
Not Yet Recruiting
More Gynaecologisch Oncologisch Centrum Zuid trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.