An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose)
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|ClinicalTrials.gov Identifier: NCT04093570|
Recruitment Status : Enrolling by invitation
First Posted : September 18, 2019
Last Update Posted : August 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Chronic Myelomonocytic Leukemia Myelodysplastic Syndromes||Drug: ASTX727||Phase 2|
The objectives of this extension study are to provide ongoing long-term treatment with ASTX727 for subjects who were benefitting from ASTX727 treatment in a previous Astex-sponsored clinical study (parent study); to obtain long-term safety information; and to obtain survival information.
Subjects will attend clinic visits on Day 1 of each 28-day cycle to undergo study procedures and to be given ASTX727 tablets for Days 1-5 of that dose cycle. Subjects should continue to receive the same ASTX727 dose and regimen they were receiving in the last cycle of the parent study in which they were originally enrolled. Subsequent treatment delays and/or dose reductions are at the discretion of the investigator as guided by the dose adjustment guidelines of the parent study protocol.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||ASTX727-06: An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose)|
|Actual Study Start Date :||September 30, 2019|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||March 31, 2021|
The recommended starting dose is the fixed-dose combination (FDC) tablet, containing 100 mg cedazuridine and 35 mg decitabine, Daily×5 in 28-day cycles. Subjects should receive ASTX727 at the same dose they received in the last cycle of their parent study; if an adjustment from that dose is required, a different total cycle dose may be employed, as guided by the dose adjustment guidelines in the parent study protocol.
Form: Tablet Route of Administration: Oral
Other Name: cedazuridine + decitabine
- Safety: Number of participants with treatment-emergent adverse events (AEs) [ Time Frame: From date of transition into this extension study until 30 days following the last dose, up to approximately 2 years ]
- Survival status: Time to death from any cause [ Time Frame: Up to approximately 2 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): NCT04093570
|Study Director:||Yuri Sano||Astex Pharmaceuticals, Inc.|