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
The purpose of this study is to identify the doses of the oral azacitidine formulations and cedazuridine (CED) tablets which achieve a total AUC for AZA comparable to that for AZA injection at 75 mg/m2
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 azacytidine (AZA) injection
Patients with an ECOG PS score of 0 or 1 or with an ECOG PS score of 2 due to primary disease-associated conditions
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
Design model
Single group
Treatments tested in this trial
ASTX030
DrugIn Cycle 1 (28 days per cycle), single dose oral azacitidine formulations will be administered on day -3, followed by subcutaneous (SC) azacitidine on day 1, oral azacitidine formulations and cedazuridine tablets on day 2-7; in Cycle 2 and onward, oral azacitidine formulations and cedazuridine tablets will be administered on day 1-7
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Azacitidine + CedazuridineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
• AUC ratio of AZA after administration of oral azacitidine formultions in combination with CED tablets compared with subcutaneous (SC) administration of AZA injection
Time frame
Up to 1 monthSponsors and contacts
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Source ClinicalTrials.gov