A clinical trial of DS-8201a in HER2 positive(HER2>=1) metastatic/recurrent uterine carcinosarcoma patients (NCCH1615,STATICE trial)
- Conditions
- uterine carcinosarcoma
- Registration Number
- JPRN-UMIN000029506
- Lead Sponsor
- ational Cancer Center
- Brief Summary
The ORR by central review in the HER2-high and HER2-low groups were 54.5% (95% CI, 32.2 to 75.6) and 70.0% (95% CI, 34.8 to 93.3) and those by investigator assessments were 68.2% and 60.0%, respectively.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 34
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate in HER2>=2+ (IHC) by central imaging review
- Secondary Outcome Measures
Name Time Method 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