NCT02953652

Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

A Phase 2b Open-Label Single Arm Study to Evaluate the Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: HUYABIO International, LLC. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Phase 2b, open-label, non-randomized, single arm study to evaluate the safety, efficacy, and pharmacokinetics of HBI-8000 40 mg BIW in patients with relapsed or refractory PTCL (R/R PTCL).

Detailed description

This is a Phase 2b, open-label, non-randomized, single arm study to evaluate the safety, efficacy, and pharmacokinetics of HBI-8000 40 mg BIW in patients with relapsed or refractory PTCL (R/R PTCL). HBI 8000 will be administered orally approximately 30 minutes after any regular meal twice a week. There will be 3-4 days between dosing. A cycle is defined as consecutive 28 days. HBI-8000 administration will be continued until disease progression or unacceptable toxicities are observed despite appropriate dose reduction or treatment interruption.

Conditions

• Peripheral T-Cell Lymphoma (PTCL)

Interventions

Type	Name	Description
DRUG	HBI-8000	Orally twice weekly

Timeline

• Start date: 2016-11-01
• Primary completion: 2022-02-17
• Completion: 2022-02-17
• First posted: 2016-11-03
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

23 sites across 2 countries: Japan, South Korea