Patients receive cabozantinib-s-malate PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients receive Cabozantinib 60mg PO QD with dose escalation to 80mg QD or dose reduction to 40mg daily or 20mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment (Cabozantinib-s-malate)

Sex: Female, Male

Race (NIH/OMB)

Region of Enrollment

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

Objective Response Rate, Defined as the Proportion of Patients Who Have Had a PR or CR as Assessed by the RECIST Version (v)1.1

Bone Turnover, as Measured by Serum and Urinary Markers of Bone Turnover

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Duration of Objective Response as Assessed by the RECIST v1.1

These baseline levels will be quantitatively summarized and graphically explored, in particular in terms of how they relate to clinical outcomes of interest. Analyses exploring differences in these angiogenic and correlative markers in relation to clinical outcomes will be largely hypothesis-generating. With limited numbers of patients patterns of difference will primarily be looked for using graphical analyses; these can include plots of these marker levels in relation to clinical outcomes to identify potential patterns of interest.

Expression Levels of Predictive Biomarkers of Response by Immunohistochemistry in Archived Tumor Tissue

Genotype of Biomarkers Potentially Predictive of Response

The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. Tolerability of the regimens will be assessed through assessing the number of patients who required dose modifications and/or dose delays. In addition, the proportion of patients who go off treatment due to adverse reactions or even those who refuse further treatment for lesser toxicities that inhibit their willingness to continue participation on the trial will be captured.

Incidence of Severe (Grade 3+) Adverse Events, Graded According to the National Cancer Institute CTCAE v4.0

Overall Survival

Side-by-side boxplots will be used to assess possible differences in this change between responders and non-responders, and scatterplots can assess the influence of baseline thyroglobulin levels on these measures of change.

Percent Change in Serum Tumor Marker Thyroglobulin Levels

Progression-free Survival

Response of Cabozantinib-s-malate in Bone Metastasis (Bone Metastasis-specific Progression Free Survival) as Evaluated by Functional Imaging

Overall Study

Manisha Shah, MD

Patients receive cabozantinib-s-malate PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cabozantinib S-malate: Given PO
Laboratory Biomarker Analysis: Correlative studies

Poorly Differentiated Thyroid Gland Carcinoma

Recurrent Thyroid Gland Carcinoma

Stage I Thyroid Gland Follicular Carcinoma

Stage I Thyroid Gland Papillary Carcinoma

Stage II Thyroid Gland Follicular Carcinoma

Stage II Thyroid Gland Papillary Carcinoma

Stage III Thyroid Gland Follicular Carcinoma

Stage III Thyroid Gland Papillary Carcinoma

Stage IVA Thyroid Gland Follicular Carcinoma

Stage IVA Thyroid Gland Papillary Carcinoma

Stage IVB Thyroid Gland Follicular Carcinoma

Stage IVB Thyroid Gland Papillary Carcinoma

Stage IVC Thyroid Gland Follicular Carcinoma

Stage IVC Thyroid Gland Papillary Carcinoma

Tall Cell Variant Thyroid Gland Papillary Carcinoma

Thyroid Gland Oncocytic Follicular Carcinoma

Cabozantinib S-malate

Laboratory Biomarker Analysis

MedStar Georgetown University Hospital

Mayo Clinic in Florida

University of Chicago Comprehensive Cancer Center

Massachusetts General Hospital Cancer Center

Mayo Clinic

Ohio State University Comprehensive Cancer Center

M D Anderson Cancer Center

Cabozantinib-S-Malate in Treating Patients With Refractory Thyroid Cancer

Phase II Study of Cabozantinib in Patients With Radioiodine-Refractory Differentiated Thyroid Cancer Who Progressed on Prior VEGFR-Targeted Therapy

National Cancer Institute (NCI)

Exelixis

Sarcoma

Positron Emission Tomography

Cross Cancer Institute

Study of 18F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Known or Suspected Soft Tissue Sarcoma

A Phase II Study of 18F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Known or Suspected Soft Tissue Sarcoma

AHS Cancer Control Alberta

fluoride

sarkom

sarcoma

fluoride/sarkom

Cabozantinib-S-Malate in Treating Patients With Refractory Thyroid Cancer

Study of 18F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Known or Suspected Soft Tissue Sarcoma

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