An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose)

Study Identifier:
ASTX727-06
CT.gov Identifier:
NCT04093570
EudraCT Identifier:
2018-003942-18
EU Trial (CTIS) Number:
2024-516293-29-01
Study Contact Information:
(210) 593-5651 or [email protected]
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Study Summary

The objectives of this extension study are to provide ongoing long-term treatment with ASTX727 for participants who were benefitting from ASTX727 treatment in a previous Astex-sponsored clinical study of ASTX727 (including, but not limited to ASTX727-01 [NCT02103478], ASTX727-02 [NCT03306264], ASTX727-04 [NCT03813186]), and Food Effect Substudy to obtain survival information and long-term safety information.

To evaluate the pharmacokinetics (PK) and safety of decitabine and cedazuridine when ASTX727 is given under fed (high-calorie/high-fat meal or low-calorie/low-fat meal) versus fasted conditions.

To provide ongoing long-term treatment with ASTX727 for subjects who were benefiting from ASTX727 treatment in a previous Astex/Taiho sponsored clinical study. To obtain long-term safety information.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Myelodysplastic Syndrome
  • Solid Tumor
  • Leukemia
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Arms:
    • Read More
  • Drug: Experimental: Substudy Arm A: ASTX727 With High-Calorie/High-Fat Breakfast Meal on Day 4
  • Drug: Participants continued treatment with ASTX727 in Cycle 2 onwards in the ASTX727-06 study at the Investigator's discretion, where they continued to receive ASTX727 unless there was occurrence of disease progression requiring alternative therapy, unacceptable toxicity, noncompliance, a decision to discontinue treatment, or if the participant withdraws from the study.
  • Drug: Experimental: Substudy Arm B: ASTX727 With Low-Calorie/Low-Fat Breakfast Meal on Day 4
  • Drug: 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 Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • Participants must fulfill all of the following inclusion criteria:
    • Previous participation in an Astex-sponsored ASTX727 clinical trial (including, but not limited to studies ASTX727-01, ASTX727-02, and ASTX727-04) in which the participant was treated with ASTX727 and was still on active treatment with ASTX727 at the time of study completion as determined by Astex.
    • Previous participation in a Taiho (formerly Astex)-sponsored ASTX727 clinical trial (including, but not limited to studies ASTX727-01, ASTX727-02, and ASTX727-04, , ASTX727-17, and ASTX727-18, and the food effect substudy of ASTX727-06) in which the participant was treated with ASTX727 and was still on active treatment with ASTX727 at the time of study completion as determined by Taiho.
    • Participant is considered to be benefitting from ASTX727 treatment in the opinion of the treating investigator at the time of parent study completion (Participants must not be withdrawn from the parent study until eligibility for this study is confirmed).
    • Participant is able to understand and comply with the study procedures and understands the risks involved in the study.
    • Participant provides legally effective informed consent before undergoing any study-specific procedure.
    • Women of childbearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of childbearing potential must agree to practice 1 highly effective contraceptive methods of birth control during the study and for 6 months after the last dose of study treatment, agree not to donate eggs for the purpose of reproduction during this period and must agree not to become pregnant for 6 months after completing treatment; men with female partners of childbearing potential must agree to practice 2 highly effective contraceptive measures and must agree not to father a child while receiving ASTX727 and for at least 3 months after completing ASTX727 treatment.
    • Inclusion Criteria for the Food Effect Substudy:
    • Participants must have a confirmed diagnosis of-
    • i. Myelodysplastic syndromes (MDS) including all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia [CMML])), and participants with MDS International Prognostic Scoring System (IPSS) int-1, int-2, or high-risk MD.
    • ii. Acute myeloid leukemia (AML), as diagnosed according to the 2016 World Health Organization (WHO) guidelines on acute leukemia, of any subtype except M3 (acute promyelocytic leukemia), who are not candidates for intensive chemotherapy, including participants receiving hypomethylating agent (HMA) treatment, who have a confirmed diagnosis and a prior confirmatory bone marrow report. Participants who are currently receiving HMA treatment must complete the ongoing (at the time of Screening) treatment cycle before enrolling in this study; timing of start of treatment cycle with ASTX727 is at the principal investigator's discretion.
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
    • Adequate organ function defined as follows:
    • Hepatic: Total bilirubin ≤1.5 × upper limit of normal (ULN); aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT) ≤5 × ULN.
    • Renal: Calculated creatinine clearance ≥60 mL/min.
    Exclusion criteria
    • 1. Any participant who, in the opinion of the investigator, may have other conditions, organ dysfunction, or for whom safety data from parent study participation suggests the risks of continuing treatment with ASTX727 may outweigh the benefits.
    • Exclusion Criteria for the Food Effect Substudy:
    • Participants with known or suspected hypersensitivity to decitabine, cedazuridine, or any of the excipients in the ASTX727 tablets.
    • Poor medical risk because of other conditions such as uncontrolled systemic diseases or active uncontrolled infections.
    • Life-threatening illness, medical condition or organ system dysfunction, or other reasons including laboratory abnormalities, which, in the Investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of decitabine + cedazuridine or compromise the integrity of the study outcomes.
    • Prior gastric surgery for ulcer disease, weight loss, etc, that would impair normal motility or absorption.
    • Second malignancy currently requiring active chemotherapy. To clarify, participants with breast or prostate cancer stable on or responding to endocrine therapy, are eligible.
    • Known history of human immunodeficiency virus or known seropositive for hepatitis C virus or hepatitis B virus.
    • Active uncontrolled gastric or duodenal ulcer.
    • Participants with acute promyelocytic leukemia.
    • Prior cytotoxic chemotherapy for AML except for hydroxyurea to control high white blood cell (WBC) counts.
    • Treated with any investigational drug or therapy within 2 weeks of study treatment, or 5 half-lives, whichever is longer, before the protocol-defined first dose of study treatment, or ongoing clinically significant AEs from previous treatment with investigational drug or therapy.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Juan José Soto
    Status
    Recruiting
    Condition(s) Treated at Site
    Myelodysplastic Syndrome
    Solid Tumor
    Leukemia
    Location
    START La Rioja
    Logroño, La Rioja, Spain, 26006
    Investigator
    Maria de Miguel
    Status
    Recruiting
    Condition(s) Treated at Site
    Myelodysplastic Syndrome
    Solid Tumor
    Leukemia
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Status
    Will Be Recruiting
    Condition(s) Treated at Site
    Myelodysplastic Syndrome
    Solid Tumor
    Leukemia