UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029506 |
|---|---|
| Receipt number | R000033713 |
| Scientific Title | A clinical trial of DS-8201a in HER2 positive(HER2>=1) metastatic/recurrent uterine carcinosarcoma patients (NCCH1615,STATICE trial) |
| Date of disclosure of the study information | 2017/10/11 |
| Last modified on | 2023/05/01 13:44:42 |
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Basic information
Public title
A clinical trial of DS-8201a in HER2 positive(HER2>=1) metastatic/recurrent uterine carcinosarcoma patients
(NCCH1615,STATICE trial)
Acronym
A clinical trial of DS-8201a in HER2 positive(HER2>=1) metastatic/recurrent uterine carcinosarcoma patients
(NCCH1615,STATICE trial)
Scientific Title
A clinical trial of DS-8201a in HER2 positive(HER2>=1) metastatic/recurrent uterine carcinosarcoma patients
(NCCH1615,STATICE trial)
Scientific Title:Acronym
A clinical trial of DS-8201a in HER2 positive(HER2>=1) metastatic/recurrent uterine carcinosarcoma patients
(NCCH1615,STATICE trial)
Region
| Japan |
Condition
Condition
uterine carcinosarcoma
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of DS-8201a in patients with metastatic/recurrent uterine carcinosarcoma showed overexpression of HER2 protein (HER2>=1) by immunohistochemistry(IHC)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Overall response rate in HER2>=2+ (IHC) by central imaging review
Key secondary outcomes
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
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
DS-8201a 6.4mg/kg or 5.4mg/kg is administered intravenously every 3weeks.
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
Female
Key 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
Key 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
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Kan |
| Middle name | |
| Last name | Yonemori |
Organization
National Cancer Center Hospital
Division name
Department of Medical Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
NCCH1615_STATICE_office@ml.res.ncc.go.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kawashima |
Organization
National Cancer Center Hospital
Division name
Clinical Trial Support Office
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
Homepage URL
NCCH1615_STATICE_office@ml.res.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Daiichi Sankyo Co.Ltd.
IRB Contact (For public release)
Organization
IRB
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.jp
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
国立がん研究センター中央病院、埼玉医科大学国際療センター、静岡県立がんセンター、愛知県がんセンター中央病院、兵庫県立がんセンター、
四国がんセンター、九州がんセンター
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 11 | Day |
Related information
URL releasing protocol
https://ascopubs.org/doi/10.1200/JCO.22.02558
Publication of results
Published
Result
URL related to results and publications
https://ascopubs.org/doi/10.1200/JCO.22.02558
Number of participants that the trial has enrolled
34
Results
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.
Results date posted
| 2023 | Year | 05 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with recurrent UCS with HER2 immunohistochemistry scores >=1+ previously treated with chemotherapy were included. Patients were assigned to the HER2-high (immunohistochemistry score >=2+; n = 22) or low (immunohistochemistry score of 1+; n = 10) groups for primary and exploratory analyses, respectively.
Participant flow
Trastuzumab deruxtecan 6.4 or 5.4 mg/kg was administered intravenously once every 3 weeks until unacceptable toxicity or disease progression.
Adverse events
Grade >= 3 adverse events occurred in 20 patients (61%). Grades 1-2 and 3 pneumonitis/interstitial lung disease occurred in eight (24%) and one (3%) patient, respectively.
Outcome measures
The median PFS and OS in the HER2-high and HER2-low groups were 6.2 and 13.3 months and 6.7 months and not reached, respectively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 11 | Day |
Last modified on
| 2023 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033713
