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Individual Patient Compassionate Use of Mirdametinib

Primary Purpose

Neurofibromatosis Type 1-Associated Plexiform Neurofibromas, Histiocytic Neoplasm, Other MAP-K Pathway Driven Diseases

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Mirdametinib (MEK Inhibitor)
Sponsored by
SpringWorks Therapeutics, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Neurofibromatosis Type 1-Associated Plexiform Neurofibromas focused on measuring RASopathies, NF1, Neurofibromatosis, Plexiform Neurofibromas, Langerhans

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Patient has a serious, debilitating or life-threatening medical condition with no suitable treatment available, has exhausted current standard of care or declined medically appropriate treatment for ethical or medical reasons.
  • Patient does not qualify to participate in any ongoing clinical trial sponsored by SpringWorks in an accessible geographical location.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    August 24, 2021
    Last Updated
    August 30, 2023
    Sponsor
    SpringWorks Therapeutics, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05028166
    Brief Title
    Individual Patient Compassionate Use of Mirdametinib
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SpringWorks Therapeutics, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    This program is being offered on a patient by patient basis and will require company, Institutional Review Board/Independent Ethics Committee and Single Patient IND approval.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neurofibromatosis Type 1-Associated Plexiform Neurofibromas, Histiocytic Neoplasm, Other MAP-K Pathway Driven Diseases
    Keywords
    RASopathies, NF1, Neurofibromatosis, Plexiform Neurofibromas, Langerhans

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Mirdametinib (MEK Inhibitor)
    Intervention Description
    Patients will receive oral mirdametinib.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Eligibility Criteria
    Inclusion Criteria: Patient has a serious, debilitating or life-threatening medical condition with no suitable treatment available, has exhausted current standard of care or declined medically appropriate treatment for ethical or medical reasons. Patient does not qualify to participate in any ongoing clinical trial sponsored by SpringWorks in an accessible geographical location.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    SpringWorks Medical Information
    Phone
    (888) 400-7989
    Email
    medinfo@springworkstx.com

    12. IPD Sharing Statement

    Learn more about this trial

    Individual Patient Compassionate Use of Mirdametinib

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