Solid cancers
Conditions
Interventions
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
drug cession until the withdrawal criteria.
Sponsors
J-Pharma Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactMikio Ishikawa
J-Pharma Co., Ltd. R & D
Outcome results
None listed