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

NCT02953652 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2024-09-19

Study results available
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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).

Conditions

  • Peripheral T-Cell Lymphoma (PTCL)

Interventions

DRUG

HBI-8000

Orally twice weekly

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • HUYABIO International, LLC.

    lead INDUSTRY

Principal Investigators

  • Gloria Lee, MD · HUYABIO International, LLC.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2022-02-17
Completion
2022-02-17

Countries

  • Japan
  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02953652 on ClinicalTrials.gov