uterine carcinosarcoma
Conditions
Interventions
DS-8201a 6.4mg/kg or 5.4mg/kg is administered intravenously every 3weeks.
Sponsors
National Cancer Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Has pathologically confirmed uterine carcinosarcoma with surgical or biopsy specimen of primary or metastatic lesion 2) Has HER2>=1+(IHC)confirmed by central pathological review 3) Metastatic and recurrent 4) Has received one or more regimen of previous chemotherapy for uterine carcinosarcoma 5) Not having any of the followings; carcinomatous meningitis, symptomatic brain metastasis and spinal metastasis requiring surgical intervention 6) Aged 20 or above 7) Performance Status(ECOG)0 or 1 8) One or more measurable lesions confirmed by contrast enhanced CT 9) Not received systematic corticosteroid at a daily dose of more than 10mg in prednisolone equivalent or immunosuppressant drug within 14 days before registration 10) Not received anti-cancer therapy including chemotherapy, molecular target therapy and immunotherapy or other investigational agents within 28 days before registration 11) Not received operation under general anesthesia within 28 days before registration 12) Not received radiotherapy at the site of lesion within 28 days before registration and not received palliative radiotherapy at the site of lesion within 14 days before registration 13) More than 50 percent of LVEF by echocardiography or MUGA within 28 days before registration 14) Correspond to the following values in laboratory tests performed within 14 days before registration without administration of G-CSF and/or blood transfusion within 14 days before the blood collection a.Neutrophil count>=1500/mm3 b.Platelet count>=100000/mm3 c.Hemoglobin>=8.5g/dL d.AST(GOT)<=100U/L(Liver metastasis:AST(GOT)<=150U/L) e.ALT(GPT)<=100U/L(Liver metastasis:AST(GOT)<=150U/L) f.Total bilirubin<=2.0mg/dL g.Creatinine<=1.5mg/dL 15) Given consent to contraception 16) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Active double cancer 2) Current or previous symptomatic congestive heart failure (NYHA class II to IV) or severe arrhythmia requiring treatment within 28 days before registration 3) Current or previous myocardial infarction or unstable angina within 6 months before registration 4) QTc >470 msec 5) Current or previous lung diseases such as interstitial pneumonitis,pulmonary fibrosis and severe radiation pneumonitis or current uncontrolled infection 6) HIV antibody-positive,HTLV-1 antibody-positive, HBs-antigen-positive,or HCV antibody-positive: except for HCV-RNA-negative even if HCV antibody-positive 7) Though HBs antigen-negative,HBs antibody-positive or HBc antibody-positive, and HCV-DNA quantitative test positive 8) Grade>=2 adverse reactions caused by prior therapy except any grade of alopecia and grade 2 peripheral neurotoxicity 9) Has confirmed hypersensitivity to the active ingredient of the investigational drug 10) Pregnant or breast-feeding women or women suspected of being pregnant 11) Psychiatric diseases or psychological symptoms interfering taking part in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate in HER2>=2+ (IHC) by central imaging review | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate in HER2>=2+ (IHC) by investigator's review Overall response rate in HER2>=1+ (IHC) by central imaging review Progression-free survival Overall survival Adverse events | — |
Countries
Japan
Contacts
Public ContactSatoshi Kawashima
National Cancer Center Hospital Clinical Trial Support Office
Outcome results
None listed