Spots Global Cancer Trial Database for A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers
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Trial Identification
Brief Title: A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers
Official Title: An Open-Label, Multicenter, Extension Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers
Study ID: NCT04093570
Interventions
Study Description
Brief 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.
Detailed 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).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Compassionate Care Research Group, Fountain Valley, California, United States
Boca Raton Clinical Research, Plantation, Florida, United States
The University of Chicago Medical Center, Chicago, Illinois, United States
The Sidney Kimmel Comprehensive Cancer Center at John Hopkins, Baltimore, Maryland, United States
Cancer and Hematology Centers for Western Michigan, Grand Rapids, Michigan, United States
Mayo - Rochester, Rochester, Minnesota, United States
Hackensack Medical Center - 06 FE Study, Hackensack, New Jersey, United States
Hackensack Medical Center, Hackensack, New Jersey, United States
Rosewell Park Cancer Institute, Buffalo, New York, United States
Roswell Park Cancer Institute - 06 FE Study, Buffalo, New York, United States
Gabrail Cancer Center Research - 06 FE Study, Canton, Ohio, United States
Gabrail Cancer Center Research, Canton, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
Charleston Hematology Oncology Associates, Charleston, South Carolina, United States
Vanderbilt - Ingram Cancer Center, Nashville, Tennessee, United States
Baylor Scott White University Medical Center, Dallas, Texas, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
May Cancer Center, San Antonio, Texas, United States
Kadlec Clinic Hematology and Oncology, Kennewick, Washington, United States
Seattle Cancer Care Alliance/Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Wiener Gesundheitsverbund - Klinik Hietzing 06 FE Study, Vienna, , Austria
Wiener Gesundheitsverbund - Klinik Hietzing 06 Study, Vienna, , Austria
Specialized Hospital for Active Treatment of Hematological Disease EAD, Sofia, , Bulgaria
University of Alberta Hospital, Edmonton, , Canada
QEII Health Sciences Centre, Nova Scotia, , Canada
The Ottawa Hosptial, Ottawa, , Canada
Sunnybrook Health Sciences Centre, Toronto, , Canada
Princess Margaret Cancer Center, Toronto, , Canada
Debreceni Egyetem Klinikai Kozpont, Belgyogyszati Klinika, B epulet, Hematologia, Debrecen, , Hungary
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
Contact Details
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