A Study of ZSTK474 in Japanese Patients With Advanced Solid Malignancies
- Registration Number
- NCT01682473
- Lead Sponsor
- Zenyaku Kogyo Co., Ltd.
- Brief Summary
To evaluate the safety (adverse events and dose-limiting toxicity) of daily oral doses of ZSTK474 in patients with advanced solid malignancies.
- Detailed Description
Open-label, uncontrolled, serial cohort, dose-escalation study evaluating two different dosing regimens (Arm 1: cycles of 5 days on drug and 2 days off drug), Arm 2: cycles of 21 days on drug and 7 days off drug).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Japanese males or females >= 20 years old
- Advanced (metastatic or unresectable) solid tumor
- ECOG performance status score of 0 or 1 and expected survival >12 weeks
- Recovered from hematological toxicities of prior cancer therapies
Exclusion Criteria
- Previous treatment with PI3K inhibitor
- Serious/significant illnesses or underlying conditions, including diabetes or hepatic renal or CV disease.
- Other investigational agent within previous 4 weeks
- Participating in another clinical study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: 5/2 Dosing ZSTK474 Subjects will receive oral ZSTK474 at a fixed once daily dose administered in 4-week (28-day) cycles of 5 days on drug and 2 days off drug. Arm 2: 21/7 Dosing ZSTK474 Subjects will receive oral ZSTK474 at a fixed once daily dose administered in 4-week (28-day) cycles of 21 days on drug and 7 days off drug.
- Primary Outcome Measures
Name Time Method Number of participants with dose-limiting toxicities 28 days
- Secondary Outcome Measures
Name Time Method Pharmacokinetics (Cmax, tmax, t½, AUC) 28 days
Trial Locations
- Locations (2)
The Cancer Institute Hospital of JFCR
🇯🇵Koto-ku, Tokyo, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa-city, Chiba, Japan