JPRN-UMIN000017777
Completed
Phase 2
The study evaluating the efficacy and safety of sorafenib in patients with differentiated thyroid cancer not amendable to radioactive iodine therapy and other alternative treatment. - RAI-skip
niversity of Tsukuba0 sites47 target enrollmentJune 2, 2015
ConditionsThyroid cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Thyroid cancer
- Sponsor
- niversity of Tsukuba
- Enrollment
- 47
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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
Outcomes
Primary Outcomes
Not specified
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