Expanded Access to Ziftomenib

Sponsor
Kura Oncology, Inc. (Industry)
Overall Status
Available
CT.gov ID
NCT05738538
Collaborator
(none)

Study Details

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

Study Design

Study Type:
Expanded Access
Official Title:
Expanded Access to Ziftomenib

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Kura Oncology, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kura Oncology, Inc.
    ClinicalTrials.gov Identifier:
    NCT05738538
    Other Study ID Numbers:
    • Expanded Access to Ziftomenib
    First Posted:
    Feb 22, 2023
    Last Update Posted:
    Feb 22, 2023
    Last Verified:
    Feb 1, 2023

    Study Results

    No Results Posted as of Feb 22, 2023