Gland and Hormone Related Diseases

All Conditions

Neoplasms

Rare Diseases

Thyroid Diseases

Thyroid Neoplasms

Thyroid Carcinoma, Anaplastic

Carcinoma

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Anaplastic Thyroid Cancer

Antineoplastic Agents

All Drugs and Chemicals

Lenvatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

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.

Iwao Sugitani, M.D., Ph.D

Makoto Tahara, M.D., Ph.D

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.

Phase II Study Assessing the Efficacy and Safety of Lenvatinib for Anaplastic Thyroid Cancer

Phase II Study Assessing the Efficacy and Safety of Lenvatinib for Anaplastic Thyroid Cancer (HOPE)

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.

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.

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).

ORR is defined as the ratio of patients who are evaluated as CR or PR in Best Overall Response (BOR).

DCR is defined as the ratio of patients who are evaluated as CR, PR or SD in Best Overall Response (BOR).

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).

Safety assessment will be assessed by the ratio of adverse event

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase II Study Assessing the Efficacy and Safety of Lenvatinib for Anaplastic Thyroid Cancer	NCT02726503	Anaplastic Thyr...	Lenvatinib	20 Years -	Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Phase II Study Assessing the Efficacy and Safety of Lenvatinib for Anaplastic Thyroid Cancer	NCT02726503	Anaplastic Thyr...	Lenvatinib	20 Years -	Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Spots Global Cancer Trial Database for anaplastic thyroid cancer, lenvatinib