Acute Myeloid Leukemia Clinical Trial

A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers

Summary

Extension study 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.

The purpose of the Food Effect Substudy is 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.

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Full Description

Main Extension Study: Participants 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. Participants 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.

Food Effect Substudy: Participants will receive ASTX727 once daily on Days 1 through 5 followed by a 23-day treatment-free period in a 28-day cycle (Cycle 1). Participants will receive either a high-calorie, high-fat breakfast meal (Arm A) or a low-calorie/low-fat breakfast meal (Arm B) predose on Day 4. Participants in Arms A and B will receive ASTX727 on Days 1, 2, 3, and 5 in the fasted condition. Participants may continue treatment with ASTX727 in Cycle 2 onwards in the ASTX727-06 study at the Investigator's discretion, where they will continue to receive ASTX727. This substudy consists of a 21-day Screening Period, a 1-cycle (28 days) Treatment Period, and a 30-day (+7 days) Safety Follow-up Period (only if the participant discontinues from the ASTX727-06 food effect substudy and does not continue to receive ASTX727 in the ASTX727-06 study).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria for the Main Extension Study:

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.
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 2 highly effective contraceptive methods of birth control 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. 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, CMML), and participants with MDS International Prognostic Scoring System (IPSS) int-1, -2, or high-risk MD.

ii. 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 Criterion for the Main Extension Study:

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.

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

332

Study ID:

NCT04093570

Recruitment Status:

Enrolling by invitation

Sponsor:

Astex Pharmaceuticals, Inc.

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There are 23 Locations for this study

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Compassionate Care Research Group
Fountain Valley California, 92708, United States
Boca Raton Clinical Research
Plantation Florida, 33322, United States
The University of Chicago Medical Center
Chicago Illinois, 60637, United States
The Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Baltimore Maryland, 21231, United States
Cancer and Hematology Centers for Western Michigan
Grand Rapids Michigan, 49503, United States
Mayo - Rochester
Rochester Minnesota, 55905, United States
Hackensack Medical Center
Hackensack New Jersey, 07601, United States
Rosewell Park Cancer Institute
Buffalo New York, 14263, United States
Gabrail Cancer Center Research
Canton Ohio, 44718, United States
Oregon Health and Science University
Portland Oregon, 92739, United States
Charleston Hematology Oncology Associates
Charleston South Carolina, 29414, United States
Henry-Joyce Cancer Clinic
Nashville Tennessee, 37232, United States
Baylor Scott White University Medical Center
Dallas Texas, 75246, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
May Cancer Center
San Antonio Texas, 78229, United States
Kadlec Clinic Hematology and Oncology
Kennewick Washington, 99336, United States
Seattle Cancer Care Alliance/Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
Wiener Gesundheitsverbund - Klinik Hietzing 06 FE Study
Vienna , , Austria
Wiener Gesundheitsverbund - Klinik Hietzing 06 Study
Vienna , , Austria
University of Alberta Hospital
Edmonton , T6G 2, Canada
QEII Health Sciences Centre
Nova Scotia , B3H 2, Canada
The Ottawa Hosptial
Ottawa , K1H 8, Canada
Sunnybrook Health Sciences Centre
Toronto , M4N 3, Canada
Princess Margaret Cancer Center
Toronto , M5G 2, Canada
Summit Clinical Research s.r.o
Bratislava , , Slovakia
Hospital Universitario 12 de Octubre
Madrid , , Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia , , Spain
Hospital Universitario La Fe
Valencia , , Spain

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

332

Study ID:

NCT04093570

Recruitment Status:

Enrolling by invitation

Sponsor:


Astex Pharmaceuticals, Inc.

How clear is this clinincal trial information?

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