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Safety Study of HBI-8000 in Japanese Patients With Non Hodgkin's Lymphoma

NCT02697552 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-01-12

No results posted yet for this study

Summary

Phase 1, open-label, non-randomized, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of HBI-8000 administered orally.

Conditions

  • Non-Hodgkin's Lymphoma

Interventions

DRUG

HBI-8000

Oral doses of 30mg, 40mg, 50mg twice weekly \[BIW\].

Sponsors & Collaborators

  • HUYABIO International, LLC.

    lead INDUSTRY

Principal Investigators

  • Kensei Tobinai, MD · National Cancer Center Hospital Tokyo, Japan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • Japan

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 NCT02697552 on ClinicalTrials.gov