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Sponsored by: |
Korea Otsuka Pharmaceutical Co.,Ltd. |
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Information provided by: | Korea Otsuka Pharmaceutical Co.,Ltd. |
ClinicalTrials.gov Identifier: | NCT00657176 |
This is an open-label, non-randomized, single-center, dose-escalation study in patients with advanced solid tumors. Six dose levels (100, 200, 400, 600, 800, and 1000 mg/day) are planned for the study. In this study, OPB-31121's potential for toxic effects will be evaluated in patients with advanced solid tumors to evaluate the recommended dose for use in subsequent studies. The pharmacokinetics and antitumor effect of the compound will also be investigated.
Condition | Intervention | Phase |
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Solid Tumor |
Drug: OPB-31121 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1, Open-Label, Non-Randomized Study of OPB-31121 in Patients With Advanced Solid Tumors |
Estimated Enrollment: | 36 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Adequate vital organ function as follows:
Bone marrow function
Hepatic function
Renal function
Exclusion criteria:
Hyperlipidemia:
Total cholesterol:more than 300 milligram per deciliter or Triglycerides:
more than 2.5 x institutional ULN
Contact: Yung-Jue Bang, PhD | 82-2-2072-2390 | bangyj@snu.ac.kr |
Contact: Hanna Lee, Bachelor | 82-2-2072-0603 | life1025@naver.com |
Korea, Republic of | |
Seoul National University Hospital | Recruiting |
Seoul, Korea, Republic of, 110-744 | |
Contact: Hanna Lee, Bachelor +82-2-2072-0603 life1025@naver.com | |
Principal Investigator: Yung-Jue Bang, PhD |
Principal Investigator: | Yung-Jue Bang, PhD | Division of Hematology and Medical Oncology, Seoul National University Hospital |
Responsible Party: | Clinical Research Team ( Sol Han / Clinical Research Associate ) |
Study ID Numbers: | 252-KOA-0701 |
Study First Received: | April 9, 2008 |
Last Updated: | April 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00657176 |
Health Authority: | Korea: Food and Drug Administration |