Safety and Pharmacokinetic Profile of CKD-581
NCT01580371 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39
Last updated 2016-10-06
Summary
This study is to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), safety and pharmacokinetics (PK) profile of a single agent CKD-581 injection in patients with Lymphoma failed to standard therapy. The usefulness of the this regimen is evaluated by response rate, progression free survival.
Conditions
Interventions
- DRUG
-
CKD-581
CKD-581 qd for Day 1, 8 and 15 every 28days/Cycle
Sponsors & Collaborators
-
Chong Kun Dang Pharmaceutical
lead INDUSTRY
Principal Investigators
-
Dok Hyun Yoon, Ph.D · 88,Olympic-ro 43-gil, Songpa-gu, Seoul 138-736, Korea
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-05-31
- Primary Completion
- 2016-03-31
- Completion
- 2016-06-30
Countries
- South Korea
Study Locations
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