UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I clinical trial of JPH203 in patients with solid cancers.
Title of the study (Brief title)	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	Junji Furuse
Organization	Kyorin University Hospital
Division name	Medical Oncology
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	Mikio Ishikawa
Organization	J-Pharma Co., Ltd.
Division name	R & D
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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