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A Study of ASTX030 (Cedazuridine in Combination with Azacitidine) in MDS, CMML, or AML
EU CTIS ID: 2024-515098-93-00
What this study is testing
Establish azacitidine AUC equivalence (90% CI 0.8, 1.25) between the final selected dose of ASTX030 from Phase 2 using FDC and SC azacitidine at 75 mg/m2/day across BSA ranges
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Must be ≥18 years
- 8. Able to swallow the number of capsules required within 10-mins and can tolerate 4 hours of fasting.
- 9. Life expectancy >= 12 weeks.
- 10. Follow contraceptive barrier requirements per protocol
- 11. Capable of giving legally effective informed consent. and willing to participate in the study.
- 2. Confirmed MDS or CMML and a candidate to receive and benefit from single-agent azacitidine according to French-American-British myelodysplastic syndrome subtypes: or MDS with intermediate-2 or high risk MDS according to the IPSS (Greenberg P, et al. Blood. 1997;89:2079-2088)
You likely can't join if
- 1. Active, uncontrolled gastric or duodenal ulcer.
- 4. Known positive for Hepatitis B or C infection with the exception of those with an undetectable viral load within 3 months of screening
- 5. Life-threatening illness, uncontrolled medical condition or organ system dysfunction, or other reasons that, could compromise the participant's safety, interfere with the absorption or metabolism of ASTX030, or the integrity of study outcomes.
- 6.History of other malignancies, except certain adequately treated and/or controlled cancers, or early-stage cases not requiring therapy.
- 7. Extramedullary disease in MDS/MPN, including palpable hepatomegaly or splenomegaly
- 8. Prior treatment with > 1 cycle of decitabine or azacitidine
See the full eligibility criteria
- 1. Must be ≥18 years
- 8. Able to swallow the number of capsules required within 10-mins and can tolerate 4 hours of fasting.
- 9. Life expectancy >= 12 weeks.
- 10. Follow contraceptive barrier requirements per protocol
- 11. Capable of giving legally effective informed consent. and willing to participate in the study.
- 2. Confirmed MDS or CMML and a candidate to receive and benefit from single-agent azacitidine according to French-American-British myelodysplastic syndrome subtypes: or MDS with intermediate-2 or high risk MDS according to the IPSS (Greenberg P, et al. Blood. 1997;89:2079-2088)
- 3. ECOG 0 or 1
- 4. Adequate organ function : a. Total or direct bilirubin ≤2 × ULN; AST/ SGOT and ALT/SGPT ≤2.5 × ULN. b. Calculated CrCl >50 mL/min by Cockcroft-Gault formula or other medically acceptable formulas.
- 5. For participants with prior allogeneic stem cell transplant, has no evidence of graft vs host disease and must be ≥3 weeks off systemic immunosuppressive therapy before study start.
- 6. No major surgery within 3 weeks before treatment initiation.
- 7. No cytotoxic chemotherapy (excluding hydroxyurea) within 4 weeks before treatment initiation
- 1. Active, uncontrolled gastric or duodenal ulcer.
- 4. Known positive for Hepatitis B or C infection with the exception of those with an undetectable viral load within 3 months of screening
- 5. Life-threatening illness, uncontrolled medical condition or organ system dysfunction, or other reasons that, could compromise the participant's safety, interfere with the absorption or metabolism of ASTX030, or the integrity of study outcomes.
- 6.History of other malignancies, except certain adequately treated and/or controlled cancers, or early-stage cases not requiring therapy.
- 7. Extramedullary disease in MDS/MPN, including palpable hepatomegaly or splenomegaly
- 8. Prior treatment with > 1 cycle of decitabine or azacitidine
- 9. Treated with any investigational therapy within 2 weeks, or 5 half-lives, whichever is longer, before treatment initiation , or has ongoing clinically significant AEs from previous treatment with investigational agent
- 10. Cannot discontinue treatment with drugs that delay gastric emptying (GLP-1 and/or GIP agonists in Cycles 1 & 2.
- 11. Known hypersensitivity to cedazuridine or azacitidine or any excipients.
- 2. Poor medical risk due to any uncontrolled systemic diseases or active uncontrolled bacterial, viral, or fungal infections.
- 3. Known HIV infection.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.