UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020773 |
|---|---|
| Receipt number | 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 11:37:11 |
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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)
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
isugitani@nms.ac.jp
Sponsor or person
Institute
Translational Research Informatics Center, Foundation for Biomedical Research and Innovation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023862
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