UMIN-CTR Clinical Trial

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 Noboru Middle name Last name Yamamoto
Organization	National Cancer Center Hospital
Division name	Department of Experimental Therapeutics
Zip code	104-0045
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 Hitoshi Middle name Last name Ozawa
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	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	NCC_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	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	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	42
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	Completed
Date of protocol fixation	2017 Year 03 Month 03 Day
Date of IRB	2017 Year 02 Month 15 Day
Anticipated trial start date	2017 Year 04 Month 13 Day
Last follow-up date	2021 Year 04 Month 30 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 03 Month 30 Day
Last modified on	2022 Year 04 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030666