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

Phase 2 Active not recruiting 47 enrolled Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. Beijing Fosun Pharmaceutical Technology Development Co., Ltd. · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a Phase 2, open-label, multicenter study to safety \& tolerability, antitumor activity, and pharmacokinetics of FCN-338 in Combination with szacitidine (AZA) or chemotherapy(erythromycin, cytarabine(Ara-C)) in Patients with myeloid neoplasms

Timeline

Start: 2023-08-16
Primary completion: 2026-12-01
Completion: 2026-12-31

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	FCN-338	Unknown	400 mg	Oral
Subject	FCN-338	Unknown	600 mg	Oral
Background	Azacitidine	Other / unclassified	50 mg/m2	Subcutaneous
Background	Azacitidine	Other / unclassified	75 mg/m2	Subcutaneous
Background	Cytarabine	Small molecule	100 mg/m2	Intravenous
Background	Cytarabine	Small molecule	1 g	Intravenous
Background	Cytarabine	Small molecule	3 g	Intravenous
Background	Erythromycin	Small molecule	60 mg/m2	Intravenous

Indications

No indication recorded.