A Phase 1 Trial of ASTX030 in Patients With Myelodysplastic Syndrome
ConditionMyelodysplastic Syndrome (MDS)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age20+
SponsorTaiho Pharmaceutical Co., Ltd.
About this trial
\[Tolerability Assessment Part\] The purpose is to identify the doses of the oral azacitidine(AZA) formulations and cedazuridine (CED) tablets which achieve a total AUC for AZA comparable to that for AZA injection at 75 mg/m2.
\[Expansion Assessment Part\] The purpose is to compare the total AUC for AZA after administration of ASTX030 with that after administration of AZA injection at 75 mg/m2.
Eligibility criteria
Qualifiers
Patients aged 20 years or older
Patients with a diagnosis of MDS (refractory anemia [RA], refractory anemia with ringed sideroblasts [RARS], refractory anemia with excess blasts [RAEB], refractory anemia with excess blasts in transformation [RAEB-T], or chronic myelomonocytic leukemia [CMML]) according to the French-American-British (FAB) classification. Low-risk patients who fall under the risk category of low or intermediate-1 (Int-1) based on the International Prognostic Scoring System (IPSS) can be enrolled only if they are unlikely to respond to any other treatment or if they are currently being treated with AZA injection.
Patients with an ECOG PS score of 0 or 1
Patients with adequate organ function as indicated below
Disqualifiers
Patients who are unlikely to respond to AZA
Patients who have received chemotherapy, hormone therapy, antibody therapy, radiotherapy, or other exploratory anti-cancer treatments for the primary disease within 3 weeks prior to the first administration of the investigational medicinal product (IMP)
Patients who have used any other IMP or any privately imported medicine within 4 weeks prior to the first administration of IMP
Patients with heart disease of Class 3 or 4 according to the New York Heart Association classification
Trial design
Treatments tested in this trial
- ASTX030 (AZA + CED)
- ASTX030 (AZA + CED)
- ASTX030 (AZA + CED)
Treatment groups
59 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov