UMIN-CTR Clinical Trial

Basic information
Public title	A phase I study of lenvatinib for unresectable adenoid cystic carcinoma of the salivary gland
Acronym	A phase I study of lenvatinib for unresectable adenoid cystic carcinoma of the salivary gland
Scientific Title	A phase I study of lenvatinib for unresectable adenoid cystic carcinoma of the salivary gland
Scientific Title:Acronym	A phase I study of lenvatinib for unresectable adenoid cystic carcinoma of the salivary gland
Region	Japan

Condition
Condition	Adenoid cystic carcinoma of the salivary gland
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety of lenvatinib for patients with unresectable adenoid cystic carcinoma of the salivary gland.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Safety All adverse events will be recorded according to CTCAE version 4.0. Grade 2 or more adverse event will be followed until the event improves to Grade 0 to 1 or beginning of other treatment for cancer, whichever comes first. Severe adverse event (SAE) will be followed and recorded until 90 days after the final administration of the study drug or beginning of other treatment for cancer, whichever comes first.
Key secondary outcomes	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	Lenvatinib is administered at a daily dose of 24 mg per day in 28-day cycles. Administration may be reduced or paused when adverse events is seen. Lenvatinib is administrated for 5 cycles maximum. However, in case that no progressive disease is observed during treatment with lenvatinib and adverse events are tolerable, lenvatinib can be administrated up to 10 cycles in the opinion of the investigator.
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Patient is eligible when he or she has: 1) Histologically or cytologically confirmed adenoid cystic carcinoma of the salivary gland which is local advanced, recurrent or metastatic. Primary sites include parotid gland, submandibular gland, sublingual gland as well as minor salivary gland of oral cavity, nasal cavity, pharynx and larynx. 2) At least one measurable lesion which is diagnosed as progressive disease (PD) according to RECIST version 1.1. 3) No history of treatment with tyrosine kinase inhibitors. Any previous surgical treatment, radiation therapy or chemotherapy is allowed. 4) ECOG Performance status (PS) of 0 or 1. 5) No central nerve system metastasis. 6) Preserved main organ function within 14 days before inclusion. 1. White blood cell count >= 3,000/mm3 2. Neutrophil count >= 1,500/mm3 3. Platelet count >= 100,000/mm3 4. AST <= 100 IU/L 5. ALT <= 100 IU/L 6. T. Bil <= 1.5 mg/dL 7. Serum Creatinine <= 1.2 mg/dL 8. Creatinine clearance >= 60 mL/min 7) Left ventricular ejection fraction (LVEF) >= 50% measured by echocardiogram within 28 days prior to inclusion. 8) No clinically significant abnormality in 12-lead electrocardiogram within 28 days prior to inclusion. 9) Blood pressure <= 150/90 mmHg. 10) Ability of oral intake. 11) Life expectancy of more than 3 months 12) Written, free-will consent with the trial.
Key exclusion criteria	Patient is excluded when he or she has: 1) Prior treatment with lenvatinib (E7080). 2) Subjects who have received any anti-cancer treatment within 21 days or any investigational agent within 30 days prior to the first dose of study drug. 3) Major surgery within 3 weeks prior to the first dose of study drug. 4) Subjects having >1+ proteinuria on urine dipstick testing will undergo 24h urine collection for quantitative assessment of proteinuria. Subjects with urine protein greater than or equal to 1g/24h will be ineligible. 5) Gastrointestinal malabsorption, or any other condition in the opinion of the investigator that might affect the absorption of lenvatinib (E7080). 6) Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina; myocardial infarction or stroke within 6 months of the first dose of study drug, or cardiac arrhythmia requiring medical treatment. 7) Prolongation of QTc interval to >480 msec. 8) Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug. 9) Active infection (any infection requiring treatment). 10) Active malignancy within the past 24 months. 11) Known intolerance to any of study drugs (or any of the excipients). 12) Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial. 13) Female who are pregnant or breastfeeding.
Target sample size	3

Research contact person
Name of lead principal investigator	1st name Nobuhiko Middle name Last name Oridate
Organization	Yokohama City University
Division name	Department of Otolaryngology-Head and Neck Surgery
Zip code	236-0004
Address	Fukuura 3-9, Kanazawa-ku, Yokohama, Japan
TEL	0457872800
Email	noridate@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Hideaki Middle name Last name Takahashi
Organization	Yokohama City University
Division name	Otolaryngology-Head and Neck Surgery
Zip code	236-0004
Address	Fukuura 3-9, Kanazawa-ku, Yokohama, Japan
TEL	0457872800
Homepage URL
Email	ttanabe@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Yokohama City University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama City University
Address	Fukuura 3-9, Kanazawa-ku, Yokohama city, Kanagawa, Japan
Tel	+81-45-787-2800
Email	chiken@yokohama-cu.ac.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	横浜市立大学附属病院

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 18 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	3
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	2015 Year 12 Month 03 Day
Date of IRB	2015 Year 12 Month 03 Day
Anticipated trial start date	2016 Year 02 Month 18 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry	2020 Year 12 Month 31 Day
Date trial data considered complete	2020 Year 12 Month 31 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 02 Month 17 Day
Last modified on	2020 Year 08 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024239