UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008807
Receipt number R000010326
Scientific Title 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
Date of disclosure of the study information 2012/08/31
Last modified on 2016/03/31 11:25:36

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Basic information

Public title

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

Acronym

A Phase 1 study of ZSTK474 in Japanese Patients with Advanced Solid Malignancies

Scientific Title

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

Scientific Title:Acronym

A Phase 1 study of ZSTK474 in Japanese Patients with Advanced Solid Malignancies

Region

Japan


Condition

Condition

Advanced Solid Malignancies

Classification by specialty

Medicine in general

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

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

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I


Assessment

Primary outcomes

1.To evaluate the safety, tolerability and dose-limiting toxicities associated with daily oral doses of ZSTK474 with advanced solid malignancies;
2.To determine the maximal tolerated dose (MTD) and/or recommended dose of ZSTK474 for Phase 2 studies.

Key secondary outcomes

1.To evaluate the pharmacokinetic (PK) profile of ZSTK474
2.Efficacy
3.To investigate several biomarkers related to the sensitivity to the PI3K inhibitor


Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Administration of ZSTK474 (5-day on drug and 2-day off drug)

Interventions/Control_2

Administration of ZSTK474 (21 days of daily dosing followed by 7 days off drug)

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Japanese Male or females >=20 years of age;
2.Histologically-confirmed advanced (metastatic or unresectable) solid tumor - for which is resistant to available therapy or available therapy is not effective;
3.ECOG performance status score of 0 or 1 and an expected survival of >12 weeks;
4.Recovered from the hematologic toxicities of prior chemotherapy, radiotherapy, and other cancer therapies;
5.Patients who are determined by Principal Investigator or Sub Investigator to be eligible to participate in the study.

Key exclusion criteria

1.Have received any investigational agents within the 4 weeks prior to the start of dosing with ZSTK474;
2.Have previously been treated with a phosphatidylinositol 3 kinase (PI3K) inhibitor;
3.Have serious or significant intercurrent illnesses or underlying diseases, including, but not limited to:
a.History of diabetes
b.Hepatic
c.Renal
d.Cardiovascular
e.Others
4.Patients who are participating in the other clinical study or at the time of informed consent of this study.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Atsushi Ohtsu M.D., Ph.D.

Organization

National Cancer Center

Division name

Exploratory Oncology Research & Clinical Trial Center

Zip code


Address

6-5-1 Kashiwanoha, Kashiwa-city, Chiba

TEL

04-7133-1111

Email

aohtsu@east.ncc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Morihiro Kanno

Organization

Zenyaku Kogyo Co., Ltd.

Division name

Prescription Products Development

Zip code


Address

6-15, Otsuka 5-Chome, Bunkyo-ku, Tokyo 112-8650

TEL

03-3946-1113

Homepage URL


Email

Morihiro_Kanno@mail.zenyaku.co.jp


Sponsor or person

Institute

Zenyaku Kogyo Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

YES

Study ID_1

NCT01682473

Org. issuing International ID_1

ClinicalTrials.gov

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

国立がん研究センター東病院(千葉県)、がん研究会有明病院(東京都)


Other administrative information

Date of disclosure of the study information

2012 Year 08 Month 31 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2012 Year 06 Month 26 Day

Date of IRB


Anticipated trial start date

2012 Year 09 Month 03 Day

Last follow-up date

2016 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 08 Month 30 Day

Last modified on

2016 Year 03 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010326


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name