Actively Recruiting
Signal TrAnsduction Pathway Activity Analysis in OVarian cancER
Led by Gynaecologisch Oncologisch Centrum Zuid · Updated on 2023-04-18
148
Participants Needed
6
Research Sites
191 weeks
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
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.
CONDITIONS
Official Title
Signal TrAnsduction Pathway Activity Analysis in OVarian cancER
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, age > 18 years
- Recurrent ovarian cancer with platinum-resistant disease (recurrence within 6 months of last platinum chemotherapy), or
- Patient refrains from standard therapy, or
- Asymptomatic but not eligible for palliative chemotherapy with rising CA125 tumor marker on two occasions 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 before study treatment
- Ability and willingness to give written and oral consent
- Able to speak and understand Dutch
- WHO performance status 0-II
- Adequate kidney and liver function to start targeted therapy
- Adequate contraception if of childbearing potential
You will not qualify if you...
- Age under 18 years
- Receiving other anti-cancer therapy or chemotherapy naive with less than 3-week washout before study
- Diagnosed or treated for a second primary tumor (except non-melanoma skin cancer) within 1 year prior
- Unable to obtain sufficient tumor material
- Previous use of the selected targeted drug as anti-cancer treatment
- Physical condition WHO III-IV
- Pregnant or breastfeeding
- Participating in another treatment-related clinical trial
- Any other significant medical condition making participation undesirable or affecting compliance, including active infection, severe psychiatric illness, or complex social situations
AI-Screening
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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
CONTACT
R
Ruud Bekkers, MD, PhD
CONTACT
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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