NCT04362007

A Phase I/II Study of ASTX660 in Patients With Relapsed or Refractory T-cell Lymphoma

A Phase I/II, Multicenter, Open-Label, Nonrandomized Study to Evaluate the Tolerability and Safety of ASTX660 and the Efficacy at the Recommended Dose of ASTX660 in Patients With Relapsed or Refractory T-Cell Lymphoma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Phase 1 (dose-escalation part): Investigate the tolerability and safety of ASTX660 in patients with r/r PTCL and r/r CTCL and determine the recommended dose (RD) for the Phase 2. Phase 1 (ATLL expansion part): Evaluate the safety of ASTX660 at RD in patients with r/r ATLL. Phase 2 : Evaluate the efficacy of ASTX660 at RD in patients with r/r PTCL.

Conditions

• Relapsed or Refractory Peripheral T-cell Lymphoma(PTCL),Cutaneous T-cell Lymphoma(CTCL),Adult T-cell Leukemia/Lymphoma(ATLL)

Interventions

Type	Name	Description
DRUG	ASTX660	Treatment of ASTX660 for r/r PTCL and r/r CTCL
DRUG	ASTX660	Treatment of ASTX660 for r/r ATLL
DRUG	ASTX660	Treatment of ASTX660 for r/r PTCL

Timeline

• Start date: 2020-07-14
• Primary completion: 2024-11-30
• Completion: 2024-11-30
• First posted: 2020-04-24
• Last updated: 2026-02-25
• Results posted: 2026-02-25

Locations

1 site across 1 country: Japan