Clinical trial · Interventional
Sunitinib Malate in Treating Patients With Iodine-Refractory Recurrent or Metastatic Thyroid Cancer
Phase II Study of Sunitinib in Iodine Refractory Differentiated Thyroid Cancer and Metastatic Medullary Carcinoma of Thyroid With Functional Imaging Correlation
NCT00519896CI-TRIAL-00027175completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II trial studies how well giving sunitinib malate works in treating patients with iodine-refractory recurrent or metastatic thyroid cancer. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_BROADER | 0.78 |
| Stage IVA Follicular Thyroid Cancer | Thyroid Gland Follicular Carcinoma | CURATED_BROADER | 0.78 |
| Stage IVA Papillary Thyroid Cancer | Thyroid Gland Papillary Carcinoma | CURATED_BROADER | 0.78 |
| Stage IVB Follicular Thyroid Cancer | Thyroid Gland Follicular Carcinoma | CURATED_BROADER | 0.78 |
| Stage IVB Papillary Thyroid Cancer | Thyroid Gland Papillary Carcinoma | CURATED_BROADER | 0.78 |
| Stage IVC Follicular Thyroid Cancer | Thyroid Gland Follicular Carcinoma | CURATED_BROADER | 0.78 |
| Stage IVC Papillary Thyroid Cancer | Thyroid Gland Papillary Carcinoma | CURATED_BROADER | 0.78 |
| Thyroid Gland Medullary Carcinoma | Thyroid Gland Medullary Carcinoma |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sunitinib malate | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (enzyme inhibitor therapy, antiangiogenesis therapy)
- description
- Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: sunitinib malate
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- At baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
- description
- Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.",
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically proven metastatic WDTC or MTC * Evidence of refractoriness to iodine therapy for WDTC documented by a combination of imaging and thyroglobulin or by biopsy * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3 * Evidence of fludeoxyglucose F 18 (FDG) PET avid metastatic tumors * Measurable disease by RECIST criteria * Resolution of all acute toxic effects of prior systemic therapy (including iodine therapy or chemotherapy), radiotherapy or surgical procedure to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 grade =\< 1 * Total serum bilirubin =\< 1.5 x upper limit of normal (ULN) (patients with Gilbert's disease exempt) * Serum transaminases =\< 2.5 x ULN or =\< 5.0 X ULN if secondary to liver metastases * Serum creatinine =\< 1.5 x ULN * Absolute neutrophil count (ANC) \>= 1.5 X 10\^9/L * Platelets \>= 100,000/uL * Hemoglobin \>= 9.0 g/dL * Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures * Male and female patients with reproductive potential must use an acceptable contraceptive method * Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment Exclusion Criteria: * Concomitant treatment in another therapeutic clinical trial * ECOG performance status \>= 3 * Symptomatic, untreated, brain metastasis * Second primary malignancy that is clinically detectable or clinically significant at the time of consideration for study enrollment * Full-dose anticoagulation defined as: * Low molecular weight heparin use with the intent of full dose anticoagulation; example: enoxaparin 1.5 mg/kg daily or equivalent * Warfarin use to keep international normalized ratio (INR) greater than or equal to 2 * History of gross hemoptysis (defined as bright red blood of at least 1/2 teaspoon or 2.5 mL per episode) within 3 months prior to study drug administration unless definitively treated with surgery or radiation * Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism; ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade \>= 2 * Type I Diabetes Mellitus; patients with Type II Diabetes Mellitus will be included as long as their glucose can be controlled between levels of 80 and 150 mg/dL * Uncontrolled Hypertension (\> 150/100 mm Hg despite optimal medical therapy) * Major surgery or radiation therapy within 4 weeks of starting the study treatment * Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study * Pregnancy or breast feeding
References
Publications (0)
Data not yet available
No reference posted for this study.