A Phase I Study of GNKG168 in Patient With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)
NCT01035216 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2014-12-23
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.
Conditions
Interventions
- DRUG
-
GNKG168
GNKG168 will be administered as a 60 minute IV infusion once daily for 5 days followed by a 9 day rest period.
Sponsors & Collaborators
-
SBI Biotech Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-09-30
- Primary Completion
- 2013-11-30
- Completion
- 2013-11-30
Countries
- United States
Study Locations
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