FCN-338 in Combination With Azacitidine or Chemotherapy in Myeloid Neoplasms

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

August 16, 2023

Primary Completion Date

December 1, 2026

Study Completion Date

December 31, 2026

Conditions
SafetyAntitumor ActivityPK Profile
Interventions
COMBINATION_PRODUCT

FCN-338 + Azacitidine

FCN-338 (400 or 600 mg, PO, QD, D1-28) combined with azacitidine (75mg/m², SC, QD, D1-7), 28 days/cycle

COMBINATION_PRODUCT

FCN-338 + erythromycin+ Ara-C

"Induction phase: FCN-338(600 mg, QD, D1-14) , erythromycin (60 mg/m², IV, QD , D1-3) and Ara-C (100 mg/m², IV, QD, D1-7) for 1 to 2 cycles.~Consolidation phase: FCN-338(600 mg, QD, D1-14) ,Ara-C (1 to 3 g/m²/12h, 6 doses) for 3 to 4 cycles Maintenance phase:FCN-338(600 mg, QD, D1-14) , azacitidine (50 mg/m², SC, QD, D1-5) for the first 12 cycles and FCN-338 (600 mg, QD, D1-14) alone for the rest 12 cycles"

Trial Locations (1)

Unknown

Union hospital tongjimedical college huzhong university of science and technology, Wuhan

All Listed Sponsors
collaborator

Beijing Fosun Pharmaceutical Technology Development Co., Ltd.

UNKNOWN

lead

Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

INDUSTRY

NCT06858618 - FCN-338 in Combination With Azacitidine or Chemotherapy in Myeloid Neoplasms | Biotech Hunter | Biotech Hunter