A Study of ZSTK474 in Japanese Patients With Advanced Solid Malignancies

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01682473

Enrollment

Registered

2012-09-11

Start date

2012-09-20

Completion date

2015-04-20

Last updated

2017-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

PI3K inhibitor, clinical trial

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).

Interventions

DRUGZSTK474

Two arms, each with serial cohorts receiving escalating doses.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of participants with dose-limiting toxicities	28 days

Secondary

Measure	Time frame
Pharmacokinetics (Cmax, tmax, t½, AUC)	28 days

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026