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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name