Thyroid cancer
Conditions
Interventions
Oral administration of 400 mg sorafenib (200mg tablet x 2) b.i.d.
Sponsors
University of Tsukuba
Tsukuba Clinical Research &
Development Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients must be able to understand and willing to sign a written informed consent 2. Age >=20 3. Patients with RAI unsuitable (i.e., RAI therapy naive and difficult to treat with RAI) 4. Not a candidate for surgery or radiotherapy with curative intent 5. Locally advanced or metastatic differentiated thyroid cancer (papillary, follicular and Hurthle cell), poorly differentiated and other thyroid variants provided that the histology has no medullary differentiation nor anaplastic features 6. Progression within 14 months (RECIST should be used as a basis for the assessment of disease progression) prior to enrollment 7. Patients with at least one measurable lesion. Lesions must be measured by CT or MRI according to RECIST v1.1 8. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements prior to enrollment: 1) Hemoglobin: > 9.0 g/dL 2) Absolute neutrophil count (ANC): > 1,500/mm3 3) Platelet count: > 100,000/mm3 4) Total bilirubin: 1.5 times the upper limit of normal (ULN) 5) ALT and AST: < 2.5 x ULN 6) PT/PT-INR and PTT: < 1.5 x ULN 7) Serum creatinine: < 1.5 x ULN 9. Patients must be able to swallow and retain oral medication 10. ECOG performance status (PS) of 0, 1 or 2 (Patients with walking difficulty caused by bone metastases are eligible regardless of PS) 11. Life expectancy of at least 12 weeks
Exclusion criteria
Exclusion criteria: 1. Histologic subtypes of thyroid cancer other than differentiated (i.e., anaplastic and medullary cancer, lymphoma or sarcoma) 2. Prior anti-cancer treatment with tyrosine kinase inhibitors, monoclonal antibodies that target VEGF or VEGF receptors or other target agents 3. Prior anti-cancer treatment for thyroid cancer with use of chemotherapy, Thalidomide or any of its derivatives 4. Use of biologic response modifiers, such as G-CSF, within 21 days of enrollment 5. Non-healing wound, ulcer, or bone fracture 6. Evidence or history of bleeding diathesis or coagulopathy disorder 7. Metastatic brain with symptom or requiring medication 8. Tracheal, bronchial or esophageal infiltration with significant risk of bleeding not treated locally prior to enrollment 9. Clinically significant cardiac disease including congestive heart failure, unstable angina, new-onset angina or myocardial infraction within the past 6 months prior to enrollment 10. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy or uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic pressure > 90 mmHg) despite optimal medical management 11. Thrombotic or embolic venous or arterial events within the past 6 months 12. Hemorrhage/bleeding event, >=Grade 3 according to NCI-CTCAE within 3 months of enrollment 13. Infection >= NCI-CTCAE Grade 3 14. Known HIV infection or infection with hepatitis B or C virus 15. Previous or concurrent active cancer affecting prognosis that is distinct in primary site or histology from thyroid cancer 16. Pregnant or breast-feeding women 17. Women and men desiring to get pregnant or bear children during the study period or within 30 days after the end of this study 18. Seizure disorder requiring medication 19. Having Renal dialysis 20. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression-free survival 2. Disease control rate 3. Tumor growth rate 4. Overall survival 5. Adverse event 6. QOL (EQ5D, EQ-VAS) | — |
Countries
Japan
Contacts
Public ContactHisato Hara
University of Tsukuba Faculty of Medicine
Outcome results
None listed