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Expanded Access to Ziftomenib

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05738538
Expanded Access Status : Available
First Posted : February 22, 2023
Last Update Posted : March 22, 2024
Sponsor:
Information provided by (Responsible Party):
Kura Oncology, Inc.

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


Condition or disease Intervention/treatment
Acute Lymphoblastic Leukemia, With Appropriate Mutations Acute Myeloid Leukemia, With NPM1 Mutations Drug: ziftomenib

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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Expanded Access to Ziftomenib




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05738538


Contacts
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Contact: Kura Oncology Expanded Access 858-500-8800 ExpandedAccess@kuraoncology.com

Sponsors and Collaborators
Kura Oncology, Inc.
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Responsible Party: Kura Oncology, Inc.
ClinicalTrials.gov Identifier: NCT05738538    
Other Study ID Numbers: Expanded Access to Ziftomenib
First Posted: February 22, 2023    Key Record Dates
Last Update Posted: March 22, 2024
Last Verified: March 2024
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Hematologic Diseases
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases