ASTX030 Trial
Phase 2/3
236
about 8 years
18+
24 sites in CA, CT, FL +12
What this study is about
Researchers are testing a new treatment, ASTX030 (cedazuridine + azacitidine), for people with certain types of blood cancers. The trial will involve different phases to determine the best way to use this treatment.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take ASTX030 (cedazuridine + azacitidine)
- 2.Take Azacitidine
- 3.Take Cedazuridine
- +1 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You are randomly assigned, but you will know your treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
azacitidine, venetoclax
injection, subcutaneous, oral
Primary: Phase 1 Combination Therapy: Cmax of Venetoclax Without ASTX030, Phase 1 Combination Therapy: Maximum Plasma Concentration (Cmax) of Venetoclax With ASTX030, Phase 1 Combination Therapy: Number of Participants with Treatment-emergent Adverse Events (TEAEs), Phase 1 and 2 Combination Therapy: Complete Response (CR) Rate as Assessed by the Investigator, Phase 1, 2 and 3 Monotherapy: Total Cycle Area Under the Curve (AUC) From 0 to 24 Hours (AUC0-24) Exposures
Secondary: Phase 1 Combination Therapy: AUC of SC Azacitidine and Venetoclax, Phase 1 Combination Therapy: AUC of Venetoclax, Azacitidine, and Cedazuridine, Phase 1 Combination Therapy: Cmax of SC Azacitidine and Venetoclax, Phase 1 Combination Therapy: Cmax of Venetoclax, Azacitidine, and Cedazuridine, Phase 1 Combination Therapy: Tmax of Venetoclax, Azacitidine, and Cedazuridine, Phase 1 and 2 Combination Therapy: CR and Complete Response with Incomplete Hematologic Recovery (CRi) Rate, Phase 1 and 2 Combination Therapy: CR and Complete Response with Partial Hematologic Recovery (CRh) Rate, Phase 1 and 2 Combination Therapy: Cmax of Azacitidine, Cedazuridine and Cedazuridine-epimer
Oncology