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Expanded Access Program for SNDX-5613

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: NCT05918913
Expanded Access Status : Available
First Posted : June 26, 2023
Last Update Posted : April 5, 2024
Sponsor:
Information provided by (Responsible Party):
Syndax Pharmaceuticals

Brief Summary:
This expanded access program will provide an investigational treatment option in a controlled clinical setting for patients who are not otherwise eligible to participate in a clinical study and have no approved treatment options.

Condition or disease Intervention/treatment
Relapsed/Refractory Acute Leukemia Drug: SNDX-5613

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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Expanded Access Program for SNDX-5613 in Patients With Relapsed/Refractory Acute Leukemias With Genetic Alterations Associated With HOXA Overexpression



Intervention Details:
  • Drug: SNDX-5613
    SNDX-5613 administered orally every 12 hours.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Days and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Key Inclusion Criteria:

  • Male or female participant aged ≥30 days.
  • Not eligible for participation in an ongoing clinical study.
  • Participant or participant's health care proxy is able and willing to provide written informed consent and able to follow study instructions.
  • Diagnosed with relapsed/refractory acute leukemia harboring a mixed lineage leukemia rearrangement, nucleoporin 98 rearrangement, nucleophosmin 1 mutation (or mutated) mutation or any other genetic alteration with overexpression of HOXA genes predicted to potentially respond to menin inhibitors.
  • Adequate liver, renal, and cardiac function
  • Adequate methods of contraception are required during childbearing age from the time of enrollment through 120 days following the last study drug dose. Barrier contraception in males and double barrier in females or other highly effective method of contraception.

For participants currently being treated with SNDX-5613 in a Syndax-sponsored clinical study the following criteria must be met:

  • In the opinion of the Investigator, participant demonstrated acceptable benefit from and tolerability of the study drug
  • Participant is considered to be compliant with study drug and procedures
  • Participant does not meet any criteria for study drug discontinuation
  • Investigator and participant agree to continue study drug treatment

Key Exclusion Criteria:

  • Evidence of uncontrolled infection
  • Pregnant or nursing women.
  • Cardiac or gastrointestinal disease.
  • Graft-Versus-Host Disease (GVHD): Signs or symptoms of acute or chronic GVHD >Grade 1 within 4 weeks of enrollment. All transplant patients must have been off all systemic immunosuppressive therapy for at least 1 week prior to enrollment and calcineurin inhibitors for at least 1 week, with the exception of steroids.
  • History of or any concurrent condition, therapy, laboratory abnormality, or allergy to excipients that, in the Investigator's opinion, either may interfere with the participant's participation or results in the conclusion that it is not in the best interest of the participant to participate.

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): NCT05918913


Contacts
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Contact: Syndax Pharmaceuticals 475-522-2022 SyndaxEAP@earlyaccesscare.com

Locations
Show Show 26 study locations
Sponsors and Collaborators
Syndax Pharmaceuticals
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Responsible Party: Syndax Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05918913    
Other Study ID Numbers: SNDX-5613-0707
First Posted: June 26, 2023    Key Record Dates
Last Update Posted: April 5, 2024
Last Verified: April 2024
Keywords provided by Syndax Pharmaceuticals:
SNDX-5613
Acute Leukemia
Refractory leukemia
Relapsed leukemia
KMT2A
NPM1
UBTF tandem duplication
Additional relevant MeSH terms:
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Leukemia
Neoplasms by Histologic Type
Neoplasms
Hematologic Diseases