Signal TrAnsduction Pathway Activity Analysis in OVarian cancER

Study acronym: STAPOVER
StatusUnknown
PhasePhase 2/3
Started

Record status This record was last updated April 18, 2023 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Apr 2023); last known: Recruiting
  2. Trial status: Not Yet Recruiting to Recruitingv5 Show 5 more changesShow less
    • Primary completion date: Oct 1, 2025 to Oct 1, 2026
    • Start date changed from estimate of Oct 1, 2022 to Jan 31, 2023
    • Primary endpoint revised
    • Site details revised at 6 of 6 sites
    • Collaborators revised (5)
  3. Phase: Phase 3 to Phase 2/3v4 Show 13 more changesShow less
    • Enrollment target: 50 to 148
    • Primary completion date: Aug 1, 2023 to Oct 1, 2025
    • Start date: Jan 1, 2021 to Oct 1, 2022
    • Primary endpoint revised
    • Study sites: 3 to 6
    • Study completion date: Dec 1, 2023 to Oct 1, 2026
    • Interventions: Itraconazole (Drug) to Bicalutamide Oral Product (Drug), Everolimus Oral Product (Drug), Itraconazole Oral Product (Drug), Letrozole Oral Product (Drug)
    • Eligibility criteria expanded, about 251 words
    • Secondary endpoints: 1 to 10
    • Study description expanded, about 74 words
    • Collaborators: 2 to 5
    • Study arms: 1 to 4
    • Study title expanded, about 2 words
  4. Primary completion date: Aug 1, 2022 to Aug 1, 2023
    • Start date: Jan 1, 2019 to Jan 1, 2021
    • Study completion date: Dec 1, 2022 to Dec 1, 2023
    v3
  5. Primary completion date: Aug 1, 2020 to Aug 1, 2022
    • Start date: Aug 1, 2018 to Jan 1, 2019
    • Study completion date: Dec 1, 2020 to Dec 1, 2022
    • Study description revised
    v2
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT03458221
Lead Sponsor Gynaecologisch Oncologisch Centrum Zuid
Collaborators: Radboud University Medical Center, Erasmus Medical Center, Maastricht University Medical Center, InnoSIGN, Eurofins
Conditions
(from sponsor)		 Recurrent Ovarian Cancer, Signal Transduction Pathway Deregulation, Therapy-Associated Cancer
Related terms Neoplasms, Second Primary, Ovarian Neoplasms
Enrollment 148 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov