UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021080 |
|---|---|
| Receipt number | R000024239 |
| Scientific Title | A phase I study of lenvatinib for unresectable adenoid cystic carcinoma of the salivary gland |
| Date of disclosure of the study information | 2016/02/18 |
| Last modified on | 2020/08/25 22:08:22 |
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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
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
ttanabe@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024239
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