NTX-301 in MDS/AML
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|ClinicalTrials.gov Identifier: NCT04167917|
Recruitment Status : Recruiting
First Posted : November 19, 2019
Last Update Posted : December 7, 2021
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Myelodysplastic Syndromes Chronic Myelomonocytic Leukemia||Drug: NTX-301||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of NTX-301, an Oral DNMT1 Inhibitor, in Patients With MDS and AML|
|Actual Study Start Date :||January 6, 2021|
|Estimated Primary Completion Date :||March 31, 2023|
|Estimated Study Completion Date :||March 31, 2025|
oral hypomethylating agent
- Safety/tolerability: Incidence of treatment related adverse events (AEs) and dose-limiting toxicities (DLTs) [ Time Frame: 3 years ]
- Efficacy: Clinical Benefit Rate (CBR) [ Time Frame: 3 years ]Clinical Benefit Rate (CBR), as defined as the percentage of participants achieving a complete remission (CR), complete marrow remission (mCR), partial remission (PR), stable disease (SD) lasting at least 8 weeks, or hematologic improvement (HI), per International Working Group (IWG) criteria.
- Efficacy: Overall response rate (ORR) [ Time Frame: 3 years ]Overall response rate (ORR), defined as the percentage of participants achieving a CR, mCR, or PR, per IWG criteria.
- Efficacy: Progression free survival (PFS) [ Time Frame: 3 years ]Progression free survival (PFS), defined as time from first dose to disease progression, as defined by IWG criteria, or death due to any cause, whichever occurs earlier.
- Efficacy: Overall survival (OS) [ Time Frame: 3 years ]Overall survival (OS), defined as time from first dose to death due to any cause.
- Pharmacodynamics (PD): Global methylation (assay) in blood and/or marrow leukemia samples [ Time Frame: 3 years ]
- Pharmacokinetics (PK): Area under the curve (AUC) [ Time Frame: 3 years ]
- Pharmacokinetics (PK): Maximum plasma concentration (Cmax) [ Time Frame: 3 years ]
- Pharmacokinetics (PK): Time to reach maximum concentration (Tmax) [ Time Frame: 3 years ]
- Pharmacokinetics (PK): Half life (t1/2) [ Time Frame: 3 years ]
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): NCT04167917
|Contact: Pankit Vachhani, MDemail@example.com|
|Contact: Pam Hardwick, RN, OCN, CCRPfirstname.lastname@example.org|