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

UMIN ID: UMIN000008807

Registered date:31/08/2012

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Advanced Solid Malignancies
• Date of first enrollment: 2012/09/03
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

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)

Outcome(s)

• Primary Outcome: 1.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 Outcome: 1.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 minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1.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

• Primary Sponsor: Zenyaku Kogyo Co., Ltd.
• Source(s) of Monetary Support: None
• Secondary ID(s): NCT01682473