At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 55 enrolled
Drug / intervention
HBI-8000drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating HBI-8000 for Peripheral T-Cell Lymphoma (PTCL). Completed, enrolled 55 participants across 23 sites in 2 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral T-Cell Lymphoma (PTCL)
CountriesJapan, South Korea
CollaboratorsIQVIA Pty Ltd
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartNov 2016
First PostedNov 2016
Primary CompletionFeb 2022
TodayJul 2026
First PostedNov 3, 2016
Enrollment StartNov 1, 2016
Primary CompletionFeb 17, 2022
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 9.7 years ago
Interventions
HBI-8000drug
Orally twice weekly