NCT02697552

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

A Phase 1 Open-label Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of HBI-8000 in Japanese Patients With Non Hodgkin's Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: HUYABIO International, LLC. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Phase 1, open-label, non-randomized, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of HBI-8000 administered orally. Patients must be hospitalized as per guidance of the treating investigator throughout Cycle 1. Patients will receive HBI 8000 twice weekly (BIW) (after breakfast), in 28 day treatment cycles. Patients will be enrolled in cohorts of 3 patients. The first cohort of 3 patients will receive 30 mg BIW. Decisions regarding cohort escalation will be based upon the clinical experience in Cycle 1 (first 28 days) only. For a given cohort, if 1 patient enrolled in the cohort experiences a dose limiting toxicity (DLT) within 28 days of the first dose, the cohort will be expanded to 6 patients.

Conditions

• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	HBI-8000	Oral doses of 30mg, 40mg, 50mg twice weekly \[BIW\].

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2016-03-03
• Last updated: 2017-01-12

Locations

8 sites across 1 country: Japan