A Study of ZSTK474 in Japanese Patients With Advanced Solid Malignancies

Zenyaku Kogyo Co., Ltd.20 enrolled

Overview

To evaluate the safety (adverse events and dose-limiting toxicity) of daily oral doses of ZSTK474 in patients with advanced solid malignancies.

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoplasms

Interventions

ZSTK474DRUG

Two arms, each with serial cohorts receiving escalating doses.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (2)

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan

Outcomes

Primary Outcomes

Number of participants with dose-limiting toxicities

Time frame: 28 days

Secondary Outcomes

Pharmacokinetics (Cmax, tmax, t½, AUC)

Time frame: 28 days

Data from ClinicalTrials.gov

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