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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016546
Receipt No. R000019155
Scientific Title Phase I clinical trial of JPH203 in patients with solid cancers.
Date of disclosure of the study information 2015/02/16
Last modified on 2018/07/25

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Basic information
Public title Phase I clinical trial of JPH203 in patients with solid cancers.
Acronym JPH203-SBECD-PI
Scientific Title Phase I clinical trial of JPH203 in patients with solid cancers.
Scientific Title:Acronym JPH203-SBECD-PI
Region
Japan

Condition
Condition Solid cancers
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Gastrointestinal surgery
Hepato-biliary-pancreatic surgery Breast surgery Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation on safety of JPH203, its recommended dose for next phase and analysis of pharmacokinetic profile in patients with solid cancers.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Safety
According to CTCAE Ver.4, category and grade of adverse effect (AE) are evaluated. All AEs, frequency of AE higher than grade 3 and relationship between AE and the study drug are estimated.
2) Estimation of maximal tolerated dose (MTD), and dose limited toxicity (DLT).
3) Determination of recommended dose (DR) for next phase trial.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 According to "Guideline for method of anti-cancer drug in clinical evaluation", the administration of study drug (JPH203-SBECD) from the first dose (12 mg/m2) to the final one (110mg/m2) is performed (seven days after single dose and the once a day repeated dose for 7days). In addition, by the decision of principal (sub-) investigator the once-a-day administration for 7 days continues in a cycle of 21+/-3days' drug cession until the withdrawal criteria.
Interventions/Control_2
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) Patient whose written informed consent has been obtained for enrollment as a subject for the clinical trial.
2) Japanese whose age is older than 20 years at the agreement.
3) Patient suffered from malignant tumor(s) diagnosed by tissue or cell examination.
4) Patient confirmed pathological lesion by imaging diagnosis (CT or MRI) in spite of whether its evaluation or not prior to 28 days before the registration (Even performed for therapy, it is possible to use the imaging taken within 28 days before registration as a selection standard).
5) Patient accepting biopsy for the anti-LAT1 antibody stain.
6) Patient being progressing disease state whose standard therapy is invalid or resistant.
7) Patient whose EOCG performance state is 0-1.
8) Patient whose life expectancy is longer than 90 days after the registration.
9) Patient who can be hospitalized during performing this trial.
10) Patient whose following data of clinical laboratory tests are fulfilled within standard values 28 days before the registration (Further, in the case existing plural laboratory data, most recent results are taken into account. Neither data are taken within 7 days receiving blood infusion nor hematopoietic preparation should be included).
Hemoglobin >9.0 g/dL
Platelet >75,000/microL
Neutrophil >1,500/mm3
AST, ALT should be lower than 2.5 fold standard values obtained in the hospital (provided that the values should be within 5 folds in the case of hepatic metastasis or icterus-lowering therapy).
Total bilirubin <1.5 folds of the standard values of the hospital.
Serum creatinine <1.5 folds of highest standard value in the hospital.
Key exclusion criteria 1) Patient with severe disorders and/or unstable complications except cancers evaluated by investigator, and psychopathy impeding informed consent, study and subject safety
2) Patient with infection required systemic therapy
3) Patient with positive HIV-1 or HCV antibody, or HBs antigen
4) Patient with ECG abnormality
5) Patient with pleural fluids, pericardial effusions or ascites required drainage
6) Patient with brain metastasis or cancerous body fluid seen by imaging.
7) Patient receiving irradiation over 1/3 of hematopoietic bone
8) Patient with frequent diarrhea or watery stool
9) Pregnant or nursing pregnant patients disagreed with contraception 90 days after last receipt of study drug.
10) Patient with continuously systemic steroid therapy
11) Patient received cyto-reductive chemotherapy, irradiation and immune therapy within 4 weeks before the trial
12) Patient whom investigator evaluates unsuitable
Target sample size 21

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junji Furuse
Organization Kyorin University Hospital
Division name Medical Oncology
Zip code
Address 6-20-2, Shinkawa, Mitaka-shi, Tokyo, Japan
TEL 0422-47-5511
Email jfuruse@ks.kyorin-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mikio Ishikawa
Organization J-Pharma Co., Ltd.
Division name R & D
Zip code
Address 75-1 Onocho, Turumi-ku, Yokohama, Japan
TEL 045-506-1155
Homepage URL
Email ishikawa@j-pharma.com

Sponsor
Institute J-Pharma Co., Ltd.
Institute
Department

Funding Source
Organization New Energy and Industrial Technology Development Organization
Organization
Division
Category of Funding Organization
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 NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 16 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
2015 Year 01 Month 06 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 19 Day
Last follow-up date
2017 Year 07 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 12 Month 27 Day

Other
Other related information

Management information
Registered date
2015 Year 02 Month 16 Day
Last modified on
2018 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019155

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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