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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026777
Receipt No. 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 2018/03/01

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Basic information
Public title Phase II trial of Lenvatinib in patients with metastatic or
recurrent thymic carcinoma;REMORA trial
(NCCH1508,REMORA trial)
Acronym Phase II trial of Lenvatinib in patients with metastatic or
recurrent thymic carcinoma
(NCCH1508,REMORA trial)
Scientific Title Phase II trial of Lenvatinib in patients with metastatic or
recurrent thymic carcinoma;REMORA trial
(NCCH1508,REMORA trial)
Scientific Title:Acronym Phase II trial of Lenvatinib in patients with metastatic or
recurrent thymic carcinoma
(NCCH1508,REMORA trial)
Region
Japan

Condition
Condition Thymic carcinoma
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response rate; Central Review
Key secondary outcomes 1)Response rate; assessed by the investigator
2)Progression Free Survival (PFS)
3)Overall Survival (OS)
4)Clinical Benefit Response (CBR)
5)Adverse Event

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 24mg of lenvatinib is orally taken once daily.
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 Male and Female
Key inclusion criteria 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
Key exclusion criteria 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)
Target sample size 42

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noboru Yamamoto
Organization National Cancer Center Hospital
Division name Department of Experimental Therapeutics
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL 03-3542-2511
Email NCCH1508_office@ml.res.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mamiko Kawasaki
Organization National Cancer Center Hospital
Division name Clinical Trial Support Office
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL 03-3542-2511
Homepage URL
Email NCCH1508_office@ml.res.ncc.go.jp

Sponsor
Institute National Cancer Center
Institute
Department

Funding Source
Organization Center for Clinical Trials, Japan Medical Association
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) Eisai Co, Ltd.

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 JMA-IIA00285
Org. issuing International ID_1 JMACCT CTR
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(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)

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2017 Year 03 Month 03 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 30 Day
Last modified on
2018 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030666

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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