Differentiated thyroid cancer
Conditions
Interventions
Treatment group:Darafenib in combination with trametinib
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) PTC patients aged 12 years or older with distant metastases (2) Histologically confirmed diagnosis of PTC at the primary site (3) BRAFV600E mutation is detected by a designated central laboratory or genetic testing company. (4) Patients with metastatic lesions that can be sized by CT scanning (5) The patient has received more than one iodine-131 treatment with therapeutic dose whole-body imaging results, and there are four of the following scenarios that are defined as radioactive iodine resistance in the 2015 edition of the ATA Guidelines: (1) no iodine uptake by the metastatic lesion at the time of initial treatment; (2) the lesion ceased to take up iodine during treatment follow-up after the lesion was treated by an iodine uptake function at the time of initial treatment; (3) part of the lesion has iodine uptake function, and part of the lesion without iodine uptake; (4) lesions with iodine uptake that progressed after treatment with iodine-131. (6) ECOG 0-1 points (7) Expected survival = 12 months (8) Willing and able to comply with the study protocol, including follow-up visits and examinations (9) Have signed a written informed consent. Subjects must be able to understand and voluntarily sign a written informed consent form (ICF) A signed ICF must be obtained prior to any trial-specific procedures, and a legal representative must sign the ICF for patients under 18 years of age. (10) Subjects must agree to adequate contraception during sexual intercourse. This will be enforced from the time the ICF is signed until 6 months after the last dose of study drug. The criteria for adequate contraception will be based on the judgement of the investigator.
Exclusion criteria
Exclusion criteria: Patient has any of the following within 14 days prior to the first dose of study drug: (1) Platelet count 2 x upper limit of normal (ULN). (5) Creatinine clearance 5.5 mg/dL. (7) QT interval (QTcF) >470 ms, history of QT prolongation syndrome or family history of QT prolongation syndrome. (8) Have uncontrolled cardiovascular disease. (9) Central nervous system (CNS) metastases or primary CNS tumours associated with progressive neurological symptoms. (10) Interstitial lung disease or interstitial pneumonia with clinical symptoms. (11) Previous treatment with BRAF or MEK inhibitors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of reversal of radioiodine avidity in tumor; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression-Free Survival;Thyroglobulin decrease index; | — |
Countries
China
Contacts
Public ContactRui Huang
West China Hospital, Sichuan University
Outcome results
None listed