A Phase 1b, Multi-Center, Open Label, Uncontrolled, Serial Cohort, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Daily Oral Doses of ZSTK474 in Subjects With Advanced Solid Malignancies

Zenyaku Kogyo Co., Ltd.3 sites in 1 country39 target enrollmentJanuary 2011

ConditionsNeoplasms

InterventionsZSTK474

DrugsZSTK474

Overview

Phase: Phase 1
Intervention: ZSTK474
Conditions: Neoplasms
Sponsor: Zenyaku Kogyo Co., Ltd.
Enrollment: 39
Locations: 3
Primary Endpoint: Maximum tolerated dose
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of daily oral doses of ZSTK474, an oral phosphatidylinositol 3-kinase (PI3K) inhibitor, in subjects with advanced solid malignancies.

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

January 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Zenyaku Kogyo Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or females ≥18 years of age;
•Histologically-confirmed advanced (metastatic or unresectable) solid tumor - for which available therapy is not effective;
•ECOG performance status score of ≤2 and an expected survival of \>8 weeks;
•Recovered from the toxicities of prior chemotherapy, radiotherapy, and other cancer therapies; all toxicities must be determined to be below Grade 2 (assessed using the NCI CTCAE v4.0).
•Adequate blood counts with a hemoglobin (Hgb) of ≥9.0 mg/dL, absolute neutrophil count (ANC) \>1,500/mm3, and platelets ≥100,000/mm3 (all without transfusion support);
•Subjects who are willing and able to provide written informed consent.
•In the expanded cohort at the MTD only: Subjects must be willing to undergo mandatory biopsies of tumor tissue twice during the first cycle (before and during dosing) and must have tumor tissue in a location accessible to incisional biopsy of a superficial lesion or percutaneous core needle biopsy on an outpatient basis without undue risk to the subject.

Exclusion Criteria

•Women who are pregnant or breastfeeding;
•Men or women of reproductive potential who are not willing to use acceptable means of contraception while on study drug and for an additional 90 days after the last dose of study drug;
•Body Mass Index (BMI) is ≥30 kg/m2;
•Have primary central nervous system (CNS) tumors or untreated/uncontrolled CNS metastases; Note: Subjects with stable/controlled CNS metastases may be enrolled (i.e., if CNS lesions have been stable in size for at least one month and the subject is off steroid and anti-convulsants).
•Have received any investigational interventional agents within the 4 weeks prior to the start of dosing with ZSTK474;
•Are receiving concurrent anti-tumor chemotherapy, radiotherapy, or immunotherapy - or have received any of these non-investigational agents within the previous 4 weeks or 5-half-lives (whichever is longer) prior to the start of dosing with ZSTK474;
•Are not able or willing to comply with the study procedures, including the study visit schedule;
•Have previously been treated with a phosphatidylinositol 3 kinase (PI3K) inhibitor;
•Have serious or significant intercurrent illnesses or underlying diseases, such as:
•Gastrointestinal disorder