UMIN-CTR Clinical Trial

Basic information
Public title	A phase II trial of lenvatinib in patients with metastatic colorectal cancer after standard chemotherapy (NCCH1503,Lemon trial)
Acronym	A phase II trial of lenvatinib in patients with metastatic colorectal cancer after standard chemotherapy (NCCH1503,Lemon trial)
Scientific Title	A phase II trial of lenvatinib in patients with metastatic colorectal cancer after standard chemotherapy (NCCH1503,Lemon trial)
Scientific Title:Acronym	A phase II trial of lenvatinib in patients with metastatic colorectal cancer after standard chemotherapy (NCCH1503,Lemon trial)
Region	Japan

Condition
Condition	colorectal cancer
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy and safety of lenvatinib in patients with metastatic colorectal cancer refractory or intolerable to standard chemotherapy (fluoropyrimidines, oxaliplatin, irinotecan, bevacizumab, TAS-102 and cetuximab or panitumumab in patients with RAS wild-type)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Disease control rate
Key secondary outcomes	Adverse events Overall response rate Progression-free survival Overall survival

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	79 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Pathologically proven colorectal adenocarcinoma 2)Unresectable metastatic colorectal cancer (except for appendiceal and anal canal cancer) 3)Refractory or intolerable to all of the following standard chemotherapy a.Fluoropyrimidines,oxaliplatin,irinotecan and bevacizumab b.Cetuximab or panitumumab in patients with RAS wild-type c.TAS-102 4)No symptomatic brain metastasis and carcinomatous meningitis 5)Oral intake 6)Aged 20 to 79 years 7)Performance Status 0 or 1 8)One or more measurable lesions confirmed by contrast enhanced CT 9)No prior treatment of lenvatinib and regorafenib 10)Not received anti-cancer therapy within 14days before registration 11)Adequately controlled blood pressure 12)Not having any of the following histories/complications a.History/complication of hypertensive crisis or hypertensive encephalopathy b.History of total gastrectomy c.History of surgery under general anesthesia or laparotomy biopsy within 28days before registration d.Complication of unrecovered wound,active gastrointestinal ulcer or bleeding from the primary lesion e.Complication of congenital hemorrhagic diathesis or coagulation disorder f.Complication of cardiovascular diseases requiring more than 325mg of aspirin daily 13)Adequate organ functions defined as below within 14days before registration a.Neutrophil count >=1500/mm3 b.Platelet count >=100000/mm3 c.Hemoglobin >=8.5g/dL d.Total bilirubin <=1.8mg/dL e.AST(GOT)<=100U/L (<=150U/L with liver metastases) f.ALT(GPT)<=100U/L (<=150U/L with liver metastases) g.Creatinine <=1.5mg/dL h.PT-INR <=1.5(<=3.0 in patients receiving any prophylactic anticoagulant agents) i.Adequate proteinuria value defined i)Negative to 1+ on urine dipstick testing ii)When >2+ on urine dipstick testing, <=1g/24hr by 24hr urine collection 14)Given consent to contraception 15)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)Grade >=2 adverse reactions caused by prior therapy except any grade of alopecia and grade 2 peripheral neurotoxicity 5)Pregnant or breast-feeding women,or women suspected of being pregnant 6)Mental disease interfering taking part in the trial 7)Taking continuous systemic steroids and/or other immunosuppressive drugs(orally or intravenously) 8)HIV antibody positive 9)Interstitial pneumonia and/or pulmonary fibrosis and/or severe pulmonary emphysema diagnosed by chest CT imaging 10)History of any of the followings; unstable angina and transient ischemic attacks within 6 months before registration, or heart attack,pulmonary embolism,deep vein thrombosis,brain bleeding,cerebral infarction and arterial thromboembolism
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Satoru Iwasa
Organization	National Cancer Center Hospital
Division name	Department of Gastrointestinal Medical Oncology
Zip code
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL	03-3542-2511
Email	siwasa@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	makawasa@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	Japan

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	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

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 02 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	30
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	2016 Year 06 Month 13 Day
Date of IRB	2016 Year 07 Month 27 Day
Anticipated trial start date	2016 Year 08 Month 23 Day
Last follow-up date	2019 Year 01 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 08 Month 02 Day
Last modified on	2020 Year 01 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027015