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Signal TrAnsduction Pathway Activity Analysis in OVarian cancER

NCT03458221 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2023-04-18

No results posted yet for this study

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.

Conditions

  • Recurrent Ovarian Cancer
  • Signal Transduction Pathway Deregulation
  • Therapy-Associated Cancer

Interventions

DRUG

Letrozole Oral Product

Letrozole 2.5mg tablet - 2.5mg once dailty until progression of disease.

DRUG

Bicalutamide Oral Product

Bicalutatmide 150mg tablet - 150mg once daily until progression of disease.

DRUG

Everolimus Oral Product

Everolimus 10mg tablet - 10mg once daily until progression of disease.

DRUG

Itraconazole Oral Product

Itraconazole 100mg capsule - 300mg twice daily until progression of disease.

Sponsors & Collaborators

  • Radboud University Medical Center

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • Maastricht University Medical Center

    collaborator OTHER

  • InnoSIGN

    collaborator UNKNOWN

  • Eurofins

    collaborator INDUSTRY

  • Gynaecologisch Oncologisch Centrum Zuid

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2026-10-01
Completion
2026-10-01

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03458221 on ClinicalTrials.gov