Unique ID issued by UMIN | UMIN000026777 |
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Receipt number | R000030666 |
Scientific Title | Phase II trial of Lenvatinib in patients with metastatic or recurrent thymic carcinoma;REMORA trial (NCCH1508,REMORA trial) |
Date of disclosure of the study information | 2017/03/30 |
Last modified on | 2022/04/06 09:40:12 |
Phase II trial of Lenvatinib in patients with metastatic or
recurrent thymic carcinoma;REMORA trial
(NCCH1508,REMORA trial)
Phase II trial of Lenvatinib in patients with metastatic or
recurrent thymic carcinoma
(NCCH1508,REMORA trial)
Phase II trial of Lenvatinib in patients with metastatic or
recurrent thymic carcinoma;REMORA trial
(NCCH1508,REMORA trial)
Phase II trial of Lenvatinib in patients with metastatic or
recurrent thymic carcinoma
(NCCH1508,REMORA trial)
Japan |
Thymic carcinoma
Chest surgery |
Malignancy
NO
The purpose of this trial is to assess the efficacy and safety of lenvatinib in patients with unresectable or recurrent thymic carcinoma, who had received at least one previous platinum-based chemo (or chemo-radio) therapy.
Safety,Efficacy
Confirmatory
Phase II
Response rate; Central Review
1)Response rate; assessed by the investigator
2)Progression Free Survival (PFS)
3)Overall Survival (OS)
4)Clinical Benefit Response (CBR)
5)Adverse Event
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
24mg of lenvatinib is orally taken once daily.
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients with thymic carcinoma confirmed by tissue or cytological diagnosis
2) Correspond to any of the following
a. Unresectable Masaoka-Koga classification IIIa or IIIb thymic carcinoma
b. Masaoka-Koga classification IVa or IVb thymic carcinoma
c. Recurrent thymic carcinoma
3) Patients who had received at least one previous platinum-based chemo (radio) therapy
4) No symptomatic brain metastasis, carcinomatous meningitis, vertebral metastasis requiring radiotherapy or surgery
5) No cardiac effusion, pleural effusion and ascites requiring any treatment
6) Aged 20 or above at the time of registration
7) Performance Status 0 or 1
8) Oral intake
9) One or more measurable lesions confirmed by contrast enhanced CT
10) No prior treatment of agents targeting the VEGFR
11) Not received anti-cancer therapy within 14days before registration
12) Not having any of the following histories/complications
a.History of hypertensive crisis or hypertensive encephalopathy
b. History of surgery under general anesthesia within 28days before registration
c. History of total gastrectomy
d.Unrecovered wound, active gastrointestinal ulcer
e.Congenital hemorrhagic diathesis or coagulation disorder
13)Adequately controlled blood pressure
14)Patients in laboratory tests performed within 14 days before registration
15) Patients who achieved an SpO2 of 92% or more under room air conditions within 14 days before registration
16) Given consent to contraception
17) Written informed consent
1) Active double cancer; synchronous or metachronous within 5years. Patients with carcinoma in situ are eligible
2) Infections requiring systemic therapy
3) Fever of >=38 degrees Celsius at the time of registration
4) Active hemoptysis (more than half a teaspoon of blood) within 21days before registration
5) Interstitial pneumonia and/or pulmonary fibrosis diagnosed by chest CT imaging or clinical examinations
6) Grade >=2 adverse reactions caused by prior therapy except any grade of alopecia
7) History of any of the followings; unstable angina within 6 months before registration, heart attack, pulmonary embolism, deep vein thrombosis, brain bleeding, cerebral infarction, transient ischemic attacks within 6 months before registration and arterial thromboembolism
8) HIV antibody positive
9) Pregnant or breast-feeding women, or women suspected of being pregnant
10) Mental disease interfering taking part in the trial
11) Taking continuous systemic steroids and/or other immunosuppressive drugs (orally or intravenously)
42
1st name | Noboru |
Middle name | |
Last name | Yamamoto |
National Cancer Center Hospital
Department of Experimental Therapeutics
104-0045
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
03-3542-2511
NCCH1508_office@ml.res.ncc.go.jp
1st name | Hitoshi |
Middle name | |
Last name | Ozawa |
National Cancer Center Hospital
Clinical Trial Support Office
104-0045
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
03-3542-2511
NCCH1508_office@ml.res.ncc.go.jp
National Cancer Center
Center for Clinical Trials, Japan Medical Association
Government offices of other countries
Eisai Co, Ltd.
NCC_IRB
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.jp
YES
JMA-IIA00285
JMACCT CTR
国立がん研究センター中央病院(東京都)、国立がん研究センター東病院(千葉県)、大阪医科大学附属病院(大阪府)、がん・感染症センター都立駒込病院(東京都)、静岡県立静岡がんセンター(静岡県)、兵庫県立がんセンター(兵庫県)、四国がんセンター(愛媛県)、北海道大学病院(北海道)
2017 | Year | 03 | Month | 30 | Day |
Published
42
Completed
2017 | Year | 03 | Month | 03 | Day |
2017 | Year | 02 | Month | 15 | Day |
2017 | Year | 04 | Month | 13 | Day |
2021 | Year | 04 | Month | 30 | Day |
2017 | Year | 03 | Month | 30 | Day |
2022 | Year | 04 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030666
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