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
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
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
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
