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UMIN ID: UMIN000008807

Registered date:31/08/2012

A Phase 1, Multi-Center, Open Label, Uncontrolled, Serial Cohort, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of ZSTK474 in Japanese Patients with Advanced Solid Malignancies

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedAdvanced Solid Malignancies
Date of first enrollment2012/09/03
Target sample size30
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Administration of ZSTK474 (5-day on drug and 2-day off drug) Administration of ZSTK474 (21 days of daily dosing followed by 7 days off drug)


Primary Outcome1.To evaluate the safety, tolerability and dose-limiting toxicities associated with daily oral doses of ZSTK474 with advanced solid malignancies; 2.To determine the maximal tolerated dose (MTD) and/or recommended dose of ZSTK474 for Phase 2 studies.
Secondary Outcome1.To evaluate the pharmacokinetic (PK) profile of ZSTK474 2.Efficacy 3.To investigate several biomarkers related to the sensitivity to the PI3K inhibitor

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1.Have received any investigational agents within the 4 weeks prior to the start of dosing with ZSTK474; 2.Have previously been treated with a phosphatidylinositol 3 kinase (PI3K) inhibitor; 3.Have serious or significant intercurrent illnesses or underlying diseases, including, but not limited to: a.History of diabetes b.Hepatic c.Renal d.Cardiovascular e.Others 4.Patients who are participating in the other clinical study or at the time of informed consent of this study.

Related Information


public contact
Name Morihiro Kanno
Address 6-15, Otsuka 5-Chome, Bunkyo-ku, Tokyo 112-8650 Japan
Telephone 03-3946-1113
Affiliation Zenyaku Kogyo Co., Ltd. Prescription Products Development
scientific contact
Name Atsushi Ohtsu M.D., Ph.D.
Address 6-5-1 Kashiwanoha, Kashiwa-city, Chiba Japan
Telephone 04-7133-1111
Affiliation National Cancer Center Exploratory Oncology Research & Clinical Trial Center