Trial Information
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
Open-label, uncontrolled, serial cohort, dose-escalation study
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of participants with dose-limiting toxicities
Outcome Time Frame:
28 days
Safety Issue:
Yes
Principal Investigator
Toshihiko Doi, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cancer Center Hospital East
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
ZSTK474-201
NCT ID:
NCT01682473
Start Date:
September 2012
Completion Date:
September 2013
Related Keywords:
- Neoplasms
- PI3K inhibitor
- clinical trial
- Neoplasms