Solid Cancer not curable with, or not eligible for standard treatment(s)
Conditions
Interventions
investigational material(s)
Generic name etc : U3-1565
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material
Sponsors
DAIICHISANKYO Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed advanced solid malignant tumor. 2) Refractory to standard treatment or for which no standard treatment is available. 3) Men or women at the age of 20-75 years (at informed consent). 4) ECOG Performance Status (PS) == 1500/microL, Platelet count: >= 100000/microL, Hb : >= 9.0 g/dL, AST: == 60 ml/min, PT or PTT : == 5 x ULN 6) Recovered or resolved to baseline values (before prior therapy) from toxicities of prior anti-cancer therapies (chemotherapy , hormonal treatment, radiation, and/or surgery). Except alopecia, skin toxicity (Grade 1), peripheral neurotoxicity (Grade 1) and fatigue (Grade 1). Graded according to CTCAE v 4.0 Japanese version. 7) Following treatment-free period prior to first administration of study drug : i) Surgery (laparotomy, thoracotomy) : 4 weeks (2 weeks for less invasive surgery, such as colostomy) ii) Radiation : 4 weeks (2 weeks for the irradiation to bone metastases (except for pelvic irradiation), and brain metastasis for pain releiefs) iii) Chemotherapy (including antibody) : 4 weeks (6 weeks for nitrosourea antineoplastic agent and mitomycin C) iv) Hormonal treatment: 4 weeks v) Pleurodesis : 2 weeks 8) Life expectancy >=3 months.
Exclusion criteria
Exclusion criteria: 1) History of any of the following disease within 6 months before enrollment or complication, as follows : Cardiac failure (NYHA>=ClassIII), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requires treatment, coronary-artery/peripheral artery bypass surgery, cerebrovascular disease, pulmonary thromboembolism, deep-vein thrombosis or clinically severe thromboembolic event, clinically severe pulmonary disease (eg, chronic obstructive pulmonary disease, asthma) 2) Any of the complication, as follows : i) Clinically severe infection that requires systemic administration of antibacterial or antiviral agents. ii) Chronic diarrhea, inflammatory bowel disease (e.g., ulcerative colitis, crohn disease) or partial bowel obstruction. iii) Fluid retention that requires treatment (e.g., pleural effusions, pericardial effusions, ascites). iv) Uncontrolled diabetes despite any medication. v) Uncontrolled hypertension despite any medication. vi) Uncontrolled psychiatric symptoms despite any medication. vii) Any concomitant medical condition that could interfere completion of protocol. 3) Suspicion of having interstitial pneumonia or pulmonary fibrosis by radiological examination (Chest CT-scan), or history of pulmonary disease (e.g., radiation pneumonia, drug induced pneumonia). 4) Cardiac dysfunction that considered to require treatment identified by echocardiography. 5) Mean QTc intervals> 450 msec for male subjects and > 470 msec for female subjects based on screening ECG. 6) Clinically active brain metastases defined as symptomatic or requiring treatment. 7) History of hematopoietic stem cell or bone marrow transplant. 8) Have a serious, nonhealing wound or unhealed bone fracture. 9) History of HBs antigen positivity, HCV antibody positivity or HIV antibody positivity 10) Active gastrointestinal hemorrhage that requires blood transfusions within 2 weeks. 11) History of severe drug sensitivity (e.g., anaphylactoid symptoms) that seriously interfere with study objectives. 12) Treatment with an investigational drug within 4 weeks before enrollment. 13) History of critical hypersensitivity to a polysorbate 20 content formulation . 14) Female subject with pregnancy (confirmed by pregnancy test) and lactation. 15) Unwilling to use adequate contraceptive methods during the study period and 6 months following the last study drug administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part1 : Safety and Pharmacokinetics (PK) Part2 : Safety , tumor response and changes in pharmacodynamic biomarkers after U3-1565 treatment Safety : AEs will be summarized for the number and percentage of subjects reporting AEs. PK : Serum concentration by each dose level and each time points will be summarized. Biomarkers : Summary tables for each time points and shift table for changes from pre-infusion will be provided for categorical data for the items according to the protocol. Tumor response : Evaluate according to RECIST ver1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part1: Tumor response, assessment of the possible formation of human anti-human antibodies (HAHA) against U3-1565, exploration of potential biomarkers Part2 : PK, assessment of the possible formation of HAHA and estimation of pharmacologically active dose for following phase PK : Serum concentration by each dose level and each time points will be summarized. HAHA : The number of HAHA findings and percentages will be summarized. Biomarkers: Summary tables for each time points and shift table for changes from pre-infusion will be provided for categorical data for the items according to the protocol. Tumor response : Evaluate according to RECIST ver1.1. | — |
Outcome results
None listed