Back to resultsExpanded 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
About this trial
This is an expanded access trial for Acute Lymphoblastic Leukemia, With Appropriate Mutations
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT05738538
First Posted
February 10, 2023
Last Updated
February 10, 2023
Sponsor
Kura Oncology, Inc.
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
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Primary Completion Date
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Study Completion Date
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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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