Signal TrAnsduction Pathway Activity Analysis in OVarian cancER
STAPOVER
2 other identifiers
interventional
148
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2023
Typical duration for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2018
CompletedFirst Posted
Study publicly available on registry
March 8, 2018
CompletedStudy Start
First participant enrolled
January 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
April 18, 2023
April 1, 2023
3.7 years
February 23, 2018
April 13, 2023
Conditions
Keywords
Outcome Measures
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
From baseline until the date of documented disease progression or 12 months after the start of targeted therapy.
Secondary Outcomes (10)
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.
From date of biopsy until the date of the result from Multi-disciplinary Tumor Board Meeting, up 14 days after biopsy date.
Proportion of patients who receive matched targeted therapy in relation to the number of patients included in each study arm.
From start date matched targeted therapy until the end of the study enrollment, up to 36 months.
Best overall response defined by RECIST 1.1 criteria based on radiological imaging.
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.
One-year survival
From start date of targeted therapy until date of death or one year follow-up, whichever comes first.
Overall survival
From start date of targeted therapy until the date of death, assessed up to 36 months.
- +5 more secondary outcomes
Study Arms (4)
A - ER active tumors
EXPERIMENTALIn case of an aberrantly active Estrogen Receptor (ER) pathway, patients will be treated with Letrozole 2.5mg daily orally until progression of disease.
B - AR active tumors
EXPERIMENTALIn case of an aberrantly active androgen receptor (AR) pathway, patients will be treated with Bicalutamide 150mg daily orally until progression of disease.
C - PI3K active tumors
EXPERIMENTALIn case of an aberrantly active phosphoinositide 3-kinase (PI3K) pathway, patients will be treated with Everolimus 10mg daily orally until progression of disease.
D - HH and/or PI3K active tumors
EXPERIMENTALIn case of an aberrantly active Hedgehog (HH) or PI3K pathway, patients will be treated with Itraconazole 300mg twice daily orally until progression of disease.
Interventions
Letrozole 2.5mg tablet - 2.5mg once dailty until progression of disease.
Bicalutatmide 150mg tablet - 150mg once daily until progression of disease.
Everolimus 10mg tablet - 10mg once daily until progression of disease.
Itraconazole 100mg capsule - 300mg twice daily until progression of disease.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynaecologisch Oncologisch Centrum Zuidlead
- Radboud University Medical Centercollaborator
- Erasmus Medical Centercollaborator
- Maastricht University Medical Centercollaborator
- InnoSIGNcollaborator
- Eurofinscollaborator
Study Sites (6)
Radboudumc
Nijmegen, Gelderland, Netherlands
Catharina Ziekenhuis
Eindhoven, North Brabant, 5623EJ, Netherlands
Amphia Hospital
Breda, 4818 CK, Netherlands
Maastricht UMC+
Maastricht, 6229 HX, Netherlands
Erasmus MC
Rotterdam, Netherlands
Elisabeth-Tweesteden Hospital
Tilburg, 5022 GC, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
February 23, 2018
First Posted
March 8, 2018
Study Start
January 31, 2023
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
April 18, 2023
Record last verified: 2023-04