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Saracatinib Trial TO Prevent FOP

Study acronym: STOPFOP
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion date changed from estimate of May 6, 2025 to Nov 30, 2025v8 Show 5 more changesShow less
    • Primary endpoint revised
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: May 6, 2025 to Nov 30, 2026
    • Secondary endpoints revised (13)
    • Site details revised at 3 of 3 sites
  2. Primary and study completion dates: Aug 1, 2024 to May 6, 2025
    • Eligibility criteria expanded, about 2 words
    v7
  3. Site details revised at 1 of 3 sitesv6
  4. Primary and study completion dates: Aug 1, 2022 to Aug 1, 2024v5
  5. Start date changed from estimate of Jun 1, 2020 to Aug 5, 2020
    • Eligibility criteria shortened, about 9 words
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Mar 13, 2020 to Jun 1, 2020v3
  2. Secondary endpoints revised (13)
    • Eligibility criteria expanded, about 1 word
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a phase 2 study, designed as a European multicentre 6-month double blind random-ized controlled trial (RCT) of AZD0530 versus matched placebo, followed by a 12 month trial comparing open-label extended AZD0530 treatment with historical control data. Study population: Male and female adult patients aged 18 years and older with a diagnosis of FOP who meet the inclusion (active disease) and exclusion criteria will be eligible for participation in this study. The total number of enrolled patients will be 20. Intervention: Patients will be randomized to receive either AZD0530 100mg once daily or matched placebo, taken orally for the first 6 months, immediately followed by an open-label extension in which all patients will receive AZD0530 100mg once daily oral dose for a further 12 months. Endpoints: Endpoints include change in number of active heterotopic bone lesions measured by low-dose whole-body computer tomography (CT)/ \[18F\] NaF Positron Emission Tomography (PET) activity
Trial Details
NCT Number NCT04307953
Lead Sponsor Amsterdam UMC, location VUmc
Collaborators: Royal National Orthopaedic Hospital NHS Trust, Klinikum Garmisch-Patenkirchen, University of Oxford, Brigham and Women's Hospital, AstraZeneca, Innovative Medicines Initiative
Conditions
(from sponsor)		 Fibrodysplasia Ossificans Progressiva
Related terms Myositis Ossificans
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov