The purpose of this phase Ⅱ study is to assess the efficacy and safety of lenvatinib for anaplastic thyroid cancer patients who are diagnosed as unresectable. The total duration of the study will be 30 months. All patients will start administration of lenvatinib within 1 week of enrollment and receive the study drug 24mg orally once daily at almost the same time. 1 cycle consists of 4 weeks. Treatment term starts on the day 1st of drug administration of cycle 1 and administration will be continued until patients meet withdrawal criteria. Safety and efficacy assesment will be conducted on a regular basis during the trial. Tumor evaluation will be conducted at 4weeks, 8 weeks, 12 weeks, 16 weeks and at every 8 weeks after the 16th week since initial administration. When study drug administration terminated,tests of the drug termination will be conducted within 7 days of withdrawal and final observation will be conducted at 30 days after the last dose. Survival survey will be conducted at follow-up term. After the termination of the study drug, survival follow up survey will be conducted every 12 weeks unless patients withdraw enrollment of this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
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.
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Fujita Health University Hospital
Toyoake, Aichi-ken, Japan
IUHW Ichikawa Hospital
Ichikawa, Chiba, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Japanese Red Cross Narita Hospital
Narita, Chiba, Japan
Kuma Hospital
Kobe, Hyōgo, Japan
Kobe Univbersity Hospital
Kobe, Hyōgo, Japan
University of Tsukuba Hospital
Tsukuba, Ibaraki, Japan
Iwate Medical University Hospital
Morioka, Iwate, Japan
Kitasato University Hospital
Sagamihara, Kanagawa, Japan
...and 13 more locations
Overall Survival (OS)
OS is defined as time frame from date of initial dose until date of death from any cause. Or until the last confirmed survival date, study cut-off date which ever comes first.
Time frame: up to 30 months
Progression-Free Survival (PFS)
PFS is defined as time frame from date of initial dose until the date of first confirmed disease progression, until date of death from any cause or the last tumor evaluating date whichever comes first.
Time frame: up to 30 months
Best Overall Response (BOR)
BOR is defined as the best total efficacy record during the date of initial dose to the date of study completion, by which evaluated with following index. Complete Response (CR), Partial Response (PR), Stable Disease (SD is defined as ≧3 weeks),Pharmacodynamics/Progressive Disease (PD) or Not Evaluable (NE).
Time frame: up to 30 months
Objective Response Rate (ORR)
ORR is defined as the ratio of patients who are evaluated as CR or PR in Best Overall Response (BOR).
Time frame: up to 30 months
Disease Control Rate (DCR)
DCR is defined as the ratio of patients who are evaluated as CR, PR or SD in Best Overall Response (BOR).
Time frame: up to 30 months
Clinical Benefit Rate (CBR)
CBR is defined as the ratio of patients who are evaluated as CR, PR or durable SD (dSD is defined as ≧11 weeks SD) in Best Overall Response (BOR).
Time frame: up to 30 months
Safety assessment on the incidence ratio of adverse events
Safety assessment will be assessed by the ratio of adverse event
Time frame: up to 30 months
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