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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020773
Receipt No. R000023862
Scientific Title Phase II study assessing the efficacy and safety of lenvatinib for anaplastic thyroid cancer (HOPE)
Date of disclosure of the study information 2016/01/28
Last modified on 2021/02/02

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Basic information
Public title Phase II study assessing the efficacy and safety of lenvatinib for anaplastic thyroid cancer (HOPE)
Acronym HOPE
Scientific Title Phase II study assessing the efficacy and safety of lenvatinib for anaplastic thyroid cancer (HOPE)
Scientific Title:Acronym HOPE
Region
Japan

Condition
Condition Anaplastic thyroid cancer
Classification by specialty
Endocrinology and Metabolism Endocrine surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the efficacy and safety of lenvatinib in patients with unresectable anaplastic thyroid cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Overall Survival (OS)
Key secondary outcomes 1) Progression-Free Survival (PFS)
2) Best Overall Response (BOR)
3) Objective Response Rate (ORR)
4) Disease Control Rate (DCR)
5) Clinical Benefit Rate (CBR)
6) Safety assessment on the incidence ratio of adverse events

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 All patients will receive lenvatinib 24 mg orally once daily at almost the same time. The treatment will be started within 1 week after enrollment. 1 cycle consists of 4 weeks.
The administration will be continued until patients meet withdrawal criteria.
If any toxicity manifested that cannot be ruled out causal association with the study drug, drug withdrawal or dosage reduction will be conducted in accordance with drug withdrawal/dosage reduction criteria.
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)Histologically confirmed as anaplastic thyroid cancer
2) Unresectable anaplastic thyroid cancer
3) Have measurable lesion defined by the RECIST version 1.1
4) Have adequate organ function and meet following laboratory value:
(a) Bone marrow function test within 14 days prior to enrollment:
neutrophil count>=1.5 x 103/microL
blood platelet count>=10.0 x 104/microL
hemoglobin amount>=9.0 g/dL
(b) Liver function test within 14 days prior to enrollment:
AST,ALT<=3.0 x ULN(without liver metastatic)
AST,ALT<=5.0 x ULN(with liver metastatic)
bilirubin<=2.0 mg/dL
(c) Kidney function test within 14 days prior to enrollment:
GFR estimation>=50 ml/min/1.73 m2
GFR estimation calculated by following formula.
Male:194 x(serum creatinine concentration)-1.094 x(Age)-0.287
Female:Male GFR estimation x 0.739
(d) Cardiac function test within 28 days prior to enrollment: 12-lead electrocardiogram: no clinically important abnormality as shown below: heart disease, severe arrhythmia etc.
5) Regardless of usage of antihypertensive drug, systolic blood pressure <=140 mm Hg and diastolic blood pressure <=90 mm Hg (If already taking antihypertensive drug, must have capacity of further
antihypertensive therapy.)
6) ECOG performance status 0-2
7) Ability to swallow oral medications
8) Life expectancy greater than 8 weeks
9) Have signed written informed consent to participate in this study
Key exclusion criteria 1) Have complications or medical history of
(a) Complication of brain metastasis
(Exclude if cured and in clinically stable condition for more than 1 month prior to screening.)
(b) Treatment required complication of systemic infectious disease
(c) Complication of pulmonary fibrosis or interstitial pneumonitis
(d) Medical history of clinically significant cardiovascular disease within 6 months of initial dose as: NYHA class above 2 leveled congestive heart failure, unstable angina, cardiac infarction or cardiac arrhythmia with paroxysmal or required treatment
e) Uncontrollable complication of diabetes mellitus
f) hemoptysis within 3 weeks of enrollment (blood volume of more than half of teaspoon)
g) Medical history of hemorrhagic or thrombotic disease within 6 months of enrollment
h) If proteinuria values above 2+ by urinary protein qualitative test, conduct 24-hour urine collection and the urine protein determined as 1g/24 hours or more. (can substitute to the ratio of proteinuria in morning urine/creatinine)
i) Malabsorption at gastrointestinal tract and any of the complication diseases that investigator considers that will be affected to lenvatinib absorption
j) Recent major surgery within 2 weeks (if needle biopsy within 1 week) of enrollment
k) Drainage required celomic fluid stagnation
2) Have history of lenvatinib administration
3) Confirmed tumor invasion to the carotid arteries
4) Have history of high dose
external radiation therapy to cervical region, and irradiated tumor location close to the carotid arteries.
5) Have any unresolved toxicity greater than 1 by CTCAE v4.0.
6)Have active double cancer
7) Female patients who are pregnant,
lactating, breast feeding or have childbearing potential
8) Psychiatric disorder and regarded by the investigator as inadequate for this study enrollment
9) Confirmed as no resistance to any component of this drug
10) Currently receiving other interventional clinical study treatment
Target sample size 39

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Iwao Sugitani, Makoto Tahara
Organization Graduate School of Medicine Nippon Medical School, National Cancer Center Hospital East
Division name Department of Endocrine Surgery, Division of Head and Neck Medical Oncology
Zip code
Address 1-1-5 Sendagi Bunkyo-ku Tokyo 113-8603, 6-5-1 Kashiwanoha, Kashiwa-shi, Chiba, 277-8577 Japan
TEL 03-5814-6219(04-7133-1111)
Email isugitani@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Iwao Sugitani, Makoto Tahara
Organization Graduate School of Medicine Nippon Medical School, National Cancer Center Hospital East
Division name Department of Endocrine Surgery, Division of Head and Neck Medical Oncology
Zip code
Address 1-1-5 Sendagi Bunkyo-ku Tokyo 113-8603, 6-5-1 Kashiwanoha, Kashiwa-shi, Chiba, 277-8577 Japan
TEL 03-5814-6219(04-7133-1111)
Homepage URL
Email isugitani@nms.ac.jp

Sponsor
Institute Translational Research Informatics Center, Foundation for Biomedical Research and Innovation
Institute
Department

Funding Source
Organization Eisai Co.,Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

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

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 28 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 Completed
Date of protocol fixation
2015 Year 10 Month 22 Day
Date of IRB
2015 Year 11 Month 27 Day
Anticipated trial start date
2016 Year 01 Month 04 Day
Last follow-up date
2019 Year 12 Month 07 Day
Date of closure to data entry
2020 Year 03 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 01 Month 28 Day
Last modified on
2021 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023862

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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