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    The value 'Show more Show more Revision: v2.9.0' has been updated to 'Show less Genetic and Rare Diseases Information Center resources: Thyroid Cancer, Medullary Neuroendocrine Tumor Neuroepithelioma Drug Information available for: Malic acid Cabozantinib Cabozantinib s-malate FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : N/A Interventional Model : Single Group Assignment Masking : None (Open Label) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : Treatment (cabozantinib S-malate) Patients receive cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Drug : Cabozantinib S-malate Given PO Other Names: BMS-907351 Cabometyx Cometriq XL-184 XL184 Other : Laboratory Biomarker Analysis Correlative studies Other : Pharmacological Study Correlative studies Primary Outcome Measures Outcome Measure Measure Description Time Frame Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose of Cabozantinib S-malate Maximum dose at which fewer than one-third of toxicity-evaluable patients experience a dose limiting toxicity during cycle 1 of therapy. Up to 28 days Number of Evaluable Patients With Dose Limiting Toxicities of Cabozantinib Number of toxicity-evaluable patients who experience a dose limiting toxicity during cycle 1 of therapy stratified by dose level and study part. Up to 28 days Clearance of Cabozantinib S-malate Median (min, max) clearance of cabozantinib stratified by dose level and study part post-dose in cycle 1, day 1. Up to 24 hours Secondary Outcome Measures Outcome Measure Measure Description Time Frame Disease Response of Cabozantinib S-malate Number of response-evaluable patients with response (CR or PR) determined by RECIST guideline (version 1.1) including CR: disappearance of all target and non-target lesions; PR: at least 30% decrease in sum of diameters of target lesions. Up to 5 years Overall Survival (OS) of Cabozantinib S-malate Median (95% CI) time to death stratified by dose level and study part. Up to 5 years Change From Baseline in VEGF-R2 Concentration Median (Min, Max) of change for VEGF-R2 sample from baseline to the day 21 or 28 stratified by dose level and study part. Up to 28 days Biomarker Response (CEA and Calcitonin) in Patients With Medullary Thyroid Cancer Treated With XL184 Number of patients with tumor markers CEA and/or calcitonin 2x ULN at baseline defined as CR (normalization of CEA or calcitonin) or PR (at least 50% decrease in CEA or CTN) at least 4 weeks apart. Up to 28 days Additional Relevant MeSH Terms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Disease Attributes Pathologic Processes Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neoplasms by Site Endocrine System Diseases Nervous System Diseases Carcinoma, Neuroendocrine Adenocarcinoma Neoplasms, Ductal, Lobular, and Medullary Endocrine Gland Neoplasms Head and Neck Neoplasms Carcinoma Neoplasms Nervous System Neoplasms Central Nervous System Neoplasms Carcinoma, Medullary Thyroid Neoplasms Thyroid Diseases Recurrence Study Documents Provided by National Cancer Institute (NCI) Study Protocol and Statistical Analysis Plan [ PDF , 1.5MB, 2019-01-31 ] Revision: v2.9.1'
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