UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016546
Receipt number 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 16:00:31

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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 or person

Institute

J-Pharma Co., Ltd.

Institute

Department

Personal name



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

Value
https://center6.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