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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008807
Receipt No. 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

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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
Institute Zenyaku Kogyo Co., Ltd.
Institute
Department

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
URL(English) https://upload.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


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