Advanced Solid Malignancies
Conditions
Interventions
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)
Sponsors
Zenyaku Kogyo Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Japanese Male or females >=20 years of age; 2.Histologically-confirmed advanced (metastatic or unresectable) solid tumor - for which is resistant to available therapy or available therapy is not effective; 3.ECOG performance status score of 0 or 1 and an expected survival of >12 weeks; 4.Recovered from the hematologic toxicities of prior chemotherapy, radiotherapy, and other cancer therapies; 5.Patients who are determined by Principal Investigator or Sub Investigator to be eligible to participate in the study.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1.To evaluate the pharmacokinetic (PK) profile of ZSTK474 2.Efficacy 3.To investigate several biomarkers related to the sensitivity to the PI3K inhibitor | — |
Countries
Japan
Contacts
Public ContactMorihiro Kanno
Zenyaku Kogyo Co., Ltd. Prescription Products Development
Outcome results
None listed