A Study of ZSTK474 in Japanese Patients With Advanced Sol... | NCT01682473

Studies
A Study of ZSTK474 in Japanese Patients With Advanced Solid Malignancies

NCT01682473

Sponsor

Zenyaku Kogyo Co., Ltd.

Status

Completed

Last Update Posted

Jul 6, 2017Actual

Enrollment

20Actual

Phase

Phase 1

Conditions

Neoplasms

Interventions

ZSTK474

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 20, 2012Actual

Primary Completion Date

Apr 2, 2015Actual

Completion Date

Apr 20, 2015Actual

First Submitted Date

Sep 4, 2012

First Submission Date that Met QC Criteria

Sep 6, 2012

First Posted Date

Sep 11, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2017

Last Update Posted Date

Jul 6, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1: 5/2 Dosing	Experimental	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.	Drug: ZSTK474
Arm 2: 21/7 Dosing	Experimental	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.	Drug: ZSTK474

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ZSTK474	Drug	Two arms, each with serial cohorts receiving escalating doses.	Arm 1: 5/2 Dosing Arm 2: 21/7 Dosing

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Toshihiko Doi, MD, PhD	National Cancer Center Hospital East	Principal Investigator
Shunji Takahashi, MD	The Cancer Institute Hospital of JFCR	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cancer Center Hospital East		Kashiwa	Chiba		Japan
The Cancer Institute Hospital of JFCR

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C510150	ZSTK474

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided