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Efficacy of Regorafenib Combined With Best Supportive Care as Maintenance Treatment in High Grade Bone Sarcomas Patients

Study acronym: REGOMAIN
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 17, 2026 (before its estimated July 21, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Site contacts updated at 2 of 16 sitesv6
  2. Enrollment target: 60 to 36v5 Show 7 more changesShow less
    • Primary endpoint revised
    • Interventions: Treatment by placebo and best supportive care (Drug), Treatment by regorafenib and best supportive care (Drug) to Treatment by regorafenib and best supportive care (Drug)
    • Secondary endpoints: 13 to 7
    • Study description shortened, about 145 words
    • Site details revised at 4 of 16 sites
    • Study arms: 2 to 1
    • Eligibility criteria expanded, about 1 word
  3. Primary and study completion dates: Jul 21, 2024 to Jul 21, 2026
    • Study sites: 14 to 16
    v4
  4. Primary completion date: Jul 21, 2023 to Jul 21, 2024
    • Eligibility criteria expanded, about 138 words
    • Study sites revised (14)
    • Study description shortened, about 1 word
    v3
  5. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Mar 1, 2021 to Jul 21, 2021
    • Primary completion date: Mar 1, 2023 to Jul 21, 2023
    • Study completion date: Mar 1, 2024 to Jul 21, 2024
    • Site details revised at 14 of 14 sites
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
Centre Leon Berard
70 trials monitored
See 2 trials at risk
Sarcoma
1,026 trials monitored
See 67 trials at risk
This is a multicenter phase II study concerning patients with high-grade bone sarcoma (HGBS) without complete remission after standard treatment at diagnosis or at relapse. Patients will be treated with regorafenib + best supportive care (BSC) for a maximum of 12 months as maintenance therapy after standard line therapy completion. Progression free rate (PFR) data will be collected and analysed for all included patients to evaluate if regorafenib + BSC can be considered as an interesting treatment for further investigations in this indication.
Trial Details
NCT Number NCT04698785
Lead Sponsor Centre Leon Berard
Conditions
(from sponsor)		 Bone Sarcoma, Osteosarcoma
Related terms Bone Neoplasms, Osteosarcoma
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov