BRAF-mutated Thyroid Cancer
Conditions
Interventions
None listed
Sponsors
Tahara Makoto
Fujiwara Akinori
ONO PHARMACEUTICAL CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Diagnosed with BRAF mutation-positive differentiated thyroid cancer* or anaplastic thyroid cancer *Other pathological types, excluding medullary thyroid cancer and anaplastic thyroid cancer, are also acceptable. 2)Newly initiated ENC+BIN combination therapy between May 17, 2024, and July 31, 2025 (Patients who have switched from the investigational drug to a commercially available medication are ineligible for enrollment) 3)Patients who are 18 years of age or older at the initiation of ENC+BIN combination therapy 4)For patients visiting the study site, written informed consent is obtained voluntarily from the patient after they have received a thorough explanation of the study and fully understood the information. Additionally, the following a) through c) are permitted. a) For patients who have difficulty writing, enrollment in this study is permitted based on the patient's oral consent, with a legally authorized representative providing written consent on their behalf. b) For patients who are unable to provide consent themselves or who are deceased, enrollment is permitted if written informed consent is obtained from their legally authorized representative after providing an explanation. c) If obtaining written consent from the research subject or their legally authorized representative is difficult, the reason for the difficulty must be documented in the medical records or equivalent. The study information should then be made publicly available to the research subjects and others, ensuring they have the opportunity to refuse participation (opt-out). Under this opt-out procedure, enrollment in the study is permitted.
Exclusion criteria
Exclusion criteria: 1)Patients who, at the start of ENC+BIN combination therapy, were prescribed a regimen other than 450 mg of ENC once daily orally and 45 mg of BIN twice daily orally (However, if adverse events occur before the second BIN dose on the first day of administration, leading to dose reduction or discontinuation, this is permitted.) 2)Having a history of multiple cancers or comorbidities within three years prior to the initiation of ENC+BIN combination therapy. 3)Participated in other interventional clinical trials or studies between the initial diagnosis of thyroid cancer and the start of ENC+BIN combination therapy. However, among patients who participated in interventional clinical trials or studies, those who received thyroid cancer treatment within the approved indications are eligible to participate in this study. 4)Patients who initiated ENC+BIN combination therapy at another hospital and have since been transferred to the study site. 5)Any other patients deemed unsuitable for enrollment in this study by the principal investigator or sub-investigators at the study site.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment Status -Patient characteristics at the initiation of ENC+BIN combination therapy (age, sex, pathological type, presence of distant metastasis, metastatic sites, etc.) -Treatment status of ENC+BIN combination therapy (duration of treatment, rates of continuation/reduction/ interruption/discontinuation, dosage, reasons for interruption/discontinuation, etc.) Effectiveness -Overall response rate assessed by the investigator according to RECIST v1.1 Safety -Incidence of adverse events within 28 days after the last dose of ENC+BIN combination therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment Status -Treatment status and effectiveness of subsequent therapies following ENC+BIN combination therapy (best overall response, duration of treatment, etc.) Effectiveness -Progression-free survival -Overall survival -Duration of response -Best overall response assessed by the investigator according to RECIST ver1.1 -Time to response -Effectiveness analysis by patient characteristics -Effectiveness analysis by prior therapy -Effectiveness analysis by drug holiday duration during ENC+BIN combination therapy Safety -Incidence of treatment-related adverse events within 28 days after the last dose of ENC+BIN combination therapy -Time to onset, outcomes, recovery/improvement rates, and time to recovery/improvement of treatment-related adverse events -Interventions for treatment-related adverse events involving ocular disorders or cardiac disorders -Information on unresolved treatment-related adverse events involving ocular disorders or cardiac disorders -Incidence of treatment-related adverse events by patient characteristics | — |
Contacts
Public ContactHitomi Nakada
WDB coco Co., Ltd.
Outcome results
None listed