ONO-7913-02 : ONO-7913 Phase 1 Study

JRCT ID: jRCT2031210139

Registered date:09/06/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Myelodysplastic Syndrome (MDS)
• Date of first enrollment: 16/08/2021
• Target sample size: 12
• Study type: Interventional
• Intervention(s): Administration of ONO-7913 with Azacitidine

Outcome(s)

• Primary Outcome: Tolerability, safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients with histological confirmation of MDS defined according to WHO classification, with an IPSS-R risk category of intermediate, high, or very high risk
2. Patients judged by the investigator or subinvestigator to be appropriate for treatment with azacitidine
3. Patients with ECOG Performance Status of 0 to 1

Exclude criteria

1. Patients who are determined to undergo allogeneic hematopoietic stem cell transplantation
2. Patients previously treated with azacitidine
3. Patients with severe complication

Related Information

• Primary Sponsor: Osawa Masahiro