Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
FEMALE
NCT03458221

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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