Actively Recruiting
Signal Transduction Pathway Activity Analysis in Recurrent Ovarian Cancer Using Targeted Therapy Based on mRNA Assay
Led by Gynaecologisch Oncologisch Centrum Zuid · Updated on 2023-04-18
148
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
Sponsors
G
Gynaecologisch Oncologisch Centrum Zuid
Lead Sponsor
R
Radboud University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new approach for women with recurrent ovarian cancer using a novel mRNA-based test called Signal Transduction Activation (STA) analysis. This technique identifies the main active signal transduction pathway (STP) driving tumor growth to guide targeted therapy with existing drugs that have manageable side effects. The goal is to improve progression-free survival and maintain quality of life by matching therapy to each patient's tumor biology. The study includes women with platinum-resistant recurrent ovarian cancer or those who are not yet eligible or who decline standard chemotherapy. After a biopsy of the recurrent tumor, STA analysis determines the dominant pathway. Patients with active estrogen receptor, androgen receptor, phosphoinositide 3-kinase, or Hedgehog pathways will receive corresponding targeted drugs such as Letrozole, Bicalutamide, Everolimus, or Itraconazole daily until disease progression. Treatment decisions are reviewed by a multidisciplinary tumor board. Participants will be monitored regularly with imaging every 12 weeks to assess tumor response and progression according to RECIST 1.1 criteria. Researchers will collect data on progression-free survival comparing current therapy to prior treatment, side effects, quality of life, and overall survival for up to 36 months. Additional evaluations include changes in pathway activity scores and health economics. The study runs up to 36 months with ongoing safety and treatment effect monitoring.
CONDITIONS
Brief Title
Signal TrAnsduction Pathway Activity Analysis in OVarian cancER
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, age over 18 years
- Recurrent ovarian cancer patient with platinum-resistant disease (recurrence or progression within 6 months after last platinum chemotherapy) or
- Patient who declines standard therapy or
- Asymptomatic patient not yet eligible for palliative chemotherapy but with increasing CA125 tumor marker on two tests 28 days apart
- Progressive disease after at least one prior systemic treatment for recurrence
- Radiologically evaluable disease by RECIST 1.1 criteria
- Ability and willingness to provide tumor biopsy after last standard treatment and before study start
- Ability and willingness to provide written and oral consent
- Able to speak and understand Dutch
- WHO performance status 0-II
- Adequate kidney and liver function to start targeted therapy (per clinician)
- Use of adequate contraceptives if of childbearing potential
You will not qualify if you...
- Age under 18 years
- Receiving any other anti-cancer therapy (cytotoxic, targeted drug, or radiation) or chemotherapy naive without 3-week washout
- Diagnosed with or treated for second primary tumor (except non-melanoma skin cancer) within 1 year prior to inclusion
- Unable to obtain sufficient tumor material
- Previous use of selected targeted drug as anti-cancer agent
- Physical condition WHO III-IV
- Pregnant or breastfeeding
- Participating simultaneously in another treatment-related clinical trial
- Any other significant medical condition making participation unsafe or compliance unlikely (e.g., active infection, severe psychiatric illness, complicated social situations)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for biopsy and eligibility assessment
Duration - Until progression of disease or up to 12 months
Participants receive targeted therapy matched to the predominant signal transduction pathway activity in their tumor, using oral drugs until disease progression.
Radiological evaluation visits every 12 weeks; side effects and quality of life assessments every 12 weeks
Duration - 12 weeks after end of treatment
Participants are monitored for side effects, quality of life, and overall survival for up to 12 weeks after treatment ends.
Follow-up visits every 12 weeks during this period
Trial Site Locations
Total: 6 locations
1
Radboudumc
Nijmegen, Gelderland, Netherlands
Not Yet Recruiting
2
Catharina Ziekenhuis
Eindhoven, North Brabant, Netherlands, 5623EJ
Actively Recruiting
3
Amphia Hospital
Breda, Netherlands, 4818 CK
Not Yet Recruiting
4
Maastricht UMC+
Maastricht, Netherlands, 6229 HX
Not Yet Recruiting
5
Erasmus MC
Rotterdam, Netherlands
Not Yet Recruiting
6
Elisabeth-Tweesteden Hospital
Tilburg, Netherlands, 5022 GC
Not Yet Recruiting
Research Team
J
Jurgen M Piek, MD, PhD
R
Ruud Bekkers, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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