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Phase I/II Trial of Everolimus in Combination With Lonafarnib in Progeria

StatusEnrolling by Invitation
PhasePhase 1/2
Started
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Record History

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  1. Primary and study completion dates: Dec 2023 to Mar 2027v10
  2. Primary completion date: Dec 2022 to Dec 2023v9
  3. Eligibility criteria shortened, about 24 wordsv8
  4. Primary completion date: Dec 2020 to Dec 2022
    • Study completion date: Dec 2021 to Dec 2023
    v7
  5. Trial status: Recruiting to Enrolling by Invitation
    • Site details revised
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Re-verified, no change to tracked fieldsv5
  2. Primary completion date: Dec 2018 to Dec 2020
    • Study completion date: Dec 2019 to Dec 2021
    v4
  3. Study completion date: Dec 2019
    • Site details revised
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Study title shortened, 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 I/II dose-escalation trial of everolimus in combination with lonafarnib in Hutchinson-Gilford Progeria Syndrome (HGPS) and progeroid laminopathies (henceforth "progeria"). The study will be conducted at a single clinical site utilizing the Clinical and Translational Study Unit (CTSU) at Boston Children's Hospital. Lonafarnib will be administered at doses previously established in the pediatric population and in this population of progeria subjects. This study will first determine the dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD) of everolimus when administered in combination with lonafarnib. It will then determine the efficacy of everolimus when administered at its MTD in combination with lonafarnib for disease in progeria.
Trial Details
NCT Number NCT02579044
Lead Sponsor Boston Children's Hospital
Conditions
(from sponsor)		 Progeria
Related terms Progeria
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov