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
|
- Study Details
- Tabular View
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Relapsed/Refractory Acute Leukemia | Drug: SNDX-5613 |
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 |
- Drug: SNDX-5613
SNDX-5613 administered orally every 12 hours.
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.
Ages Eligible for Study: | 30 Days and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
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.
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
Contact: Syndax Pharmaceuticals | 475-522-2022 | SyndaxEAP@earlyaccesscare.com |
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 |
SNDX-5613 Acute Leukemia Refractory leukemia Relapsed leukemia |
KMT2A NPM1 UBTF tandem duplication |
Leukemia Neoplasms by Histologic Type Neoplasms Hematologic Diseases |