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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Letrozole Oral Product
DrugLetrozole 2.5mg tablet - 2.5mg once dailty until progression of disease.
Bicalutamide Oral Product
DrugBicalutatmide 150mg tablet - 150mg once daily until progression of disease.
Everolimus Oral Product
DrugEverolimus 10mg tablet - 10mg once daily until progression of disease.
Itraconazole Oral Product
DrugItraconazole 100mg capsule - 300mg twice daily until progression of disease.
Treatment groups
148 Participants
are divided into 4 treatment groupsGroup A: A - ER active tumorsExperimental treatment 1 intervention
Group B: B - AR active tumorsExperimental treatment 1 intervention
Group C: C - PI3K active tumorsExperimental treatment 1 intervention
Group D: D - HH and/or PI3K active tumorsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
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
Time frame
From baseline until the date of documented disease progression or 12 months after the start of targeted therapy.Secondary outcomes
1
Proportion of patients with an actionable active pathway for which targeted therapy is recommended in relation to the number of patients who underwent a biopsy.
Time frame
From date of biopsy until the date of the result from Multi-disciplinary Tumor Board Meeting, up 14 days after biopsy date.2
Proportion of patients who receive matched targeted therapy in relation to the number of patients included in each study arm.
Proportion of patients included in arm A, B, C, D.
Time frame
From start date matched targeted therapy until the end of the study enrollment, up to 36 months.3
Best overall response defined by RECIST 1.1 criteria based on radiological imaging.
Time frame
From baseline, radiological evaluation every 12 weeks after the start of targeted therapy until the date of documented disease progression or death, whichever comes first, assessed up to 12 months.4
One-year survival
One-year survival is defined as the time from start matched targeted therapy till death or the end of the one-year follow-up period.
Time frame
From start date of targeted therapy until date of death or one year follow-up, whichever comes first.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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