Signal TrAnsduction Pathway Activity Analysis in OVarian cancER
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorGynaecologisch Oncologisch Centrum Zuid
About this trial
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 criteria
Qualifiers
Female, age > 18 years
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Letrozole Oral Product
- Bicalutamide Oral Product
- Everolimus Oral Product
- Itraconazole Oral Product
Treatment groups
148 Participants
are divided into 4 treatment groupsSponsors and collaborators
Gynaecologisch Oncologisch Centrum Zuid
Lead sponsor
Catharina Ziekenhuis Eindhoven
Sponsor institution
Radboud University Medical Center
Collaborator
Erasmus Medical Center
Collaborator
Maastricht University Medical Center
Collaborator
InnoSIGN
Collaborator
Eurofins
Collaborator
Source ClinicalTrials.gov