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Expanded Access to Ziftomenib

Primary Purpose

Acute Lymphoblastic Leukemia, With Appropriate Mutations, Acute Myeloid Leukemia, With NPM1 Mutations

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
ziftomenib
Sponsored by
Kura Oncology, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Acute Lymphoblastic Leukemia, With Appropriate Mutations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion/Exclusion Criteria: Diagnosed with Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL) Adult, ages 18+ Has exhausted appropriate standard treatments without success and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition. Is ineligible for participation in any ongoing clinical study of the investigational drug, which includes lack of access due to geographic limitations. Meets any other pertinent medical criteria for access to the investigational drug, as established by Kura Oncology For AML patients: Does not have KMT2A rearrangement

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 10, 2023
    Last Updated
    February 10, 2023
    Sponsor
    Kura Oncology, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05738538
    Brief Title
    Expanded Access to Ziftomenib
    Official Title
    Expanded Access to Ziftomenib
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    February 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
    Kura Oncology, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    Requests for single patient expanded access to ziftomenib monotherapy may be considered for eligible adult patients with Acute Lymphoblastic Leukemia (ALL), with appropriate mutations, or Acute Myeloid Leukemia (AML), with NPM1 mutations. To request access, use Responsible Party contact information provided in this record. Expanded access for ziftomenib is only available in the United States

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Lymphoblastic Leukemia, With Appropriate Mutations, Acute Myeloid Leukemia, With NPM1 Mutations

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    ziftomenib

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion/Exclusion Criteria: Diagnosed with Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL) Adult, ages 18+ Has exhausted appropriate standard treatments without success and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition. Is ineligible for participation in any ongoing clinical study of the investigational drug, which includes lack of access due to geographic limitations. Meets any other pertinent medical criteria for access to the investigational drug, as established by Kura Oncology For AML patients: Does not have KMT2A rearrangement
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kura Oncology Expanded Access
    Phone
    858-500-8800
    Email
    ExpandedAccess@kuraoncology.com

    12. IPD Sharing Statement

    Learn more about this trial

    Expanded Access to Ziftomenib

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