drugset / Trial / NCT01035216

A Phase I Study of GNKG168 in Patient With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)

NCT01035216

Phase 1 Terminated 18 enrolled SBI Biotech Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, dose escalation study designed to characterize the safety, tolerability, efficacy, and pharmacokinetics of GNKG168 in patients with B-CLL that has relapsed or is refractory to all prior standard therapy, or for which no standard therapy exists.

Timeline

Start
2009-09
Primary completion
2013-11
Completion
2013-11

Drugs

EvaluationDrugModalityDoseRoute
Subject GNKG168 Oligonucleotide (other) 0.15 mg/kg Intravenous
Subject GNKG168 Oligonucleotide (other) 0.25 mg/kg Intravenous
Subject GNKG168 Oligonucleotide (other) 0.5 mg/kg Intravenous
Subject GNKG168 Oligonucleotide (other) 0.75 mg/kg Intravenous
Subject GNKG168 Oligonucleotide (other) 1 mg/kg Intravenous
Subject GNKG168 Oligonucleotide (other) 1.5 mg/kg Intravenous

Indications