A Study of ZSTK474 in Japanese Patients With Advanced Solid Malignancies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-20

Study Completion Date

2015-04-20

Brief Summary

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

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Detailed Description

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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).

Conditions

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Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1: 5/2 Dosing

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.

Group Type EXPERIMENTAL

ZSTK474

Intervention Type DRUG

Two arms, each with serial cohorts receiving escalating doses.

Arm 2: 21/7 Dosing

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.

Group Type EXPERIMENTAL

ZSTK474

Intervention Type DRUG

Two arms, each with serial cohorts receiving escalating doses.

Interventions

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ZSTK474

Two arms, each with serial cohorts receiving escalating doses.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No