Cabozantinib in Recurrent/Metastatic Merkel Cell Carcinoma

Exclusion Criteria

• •Participants who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier
• •Participants may not be receiving any biologics or investigational agents within 3 weeks
• •The subject has active brain metastases or epidural disease
• •History of allergic reactions attributed to compounds of similar chemical or biologic composition to cabozantinib
• •Has prothrombin time (PT)/ International Normalized Ratio (INR) or partial thromboplastin time (PTT) test ≥ 1.3 the institutional ULN within 7 days before the first dose of study treatment, unless PT/PTT prolongation known to be secondary to conditions not associated with increased bleeding risk (as on antiphospholipid antibody syndrome)
• •Requires concomitant treatment, in therapeutic doses, with anticoagulants
• •Active bleeding or pathologic conditions that carry high risk of bleeding
• •Have experienced clinically significant gastrointestinal bleeding within 6 months before first dose of study treatment
• •Requires chronic concomitant treatment of strong CYP3A4 inducers
• •Is unable or unwilling to swallow tablets
• •Has a corrected QT interval calculated by the Fridericia formula (QTcF)\>500 ms within 28 days before initiation of cabozantinib
• •Has evidence of tumor invading the GI tract or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib
• •Has radiographic evidence of cavitating pulmonary lesion(s)
• •Has uncontrolled, significant intercurrent or recent illness
• •Other disorders associated with a high risk of fistula formation including PEG tube placement within 3 months before the first dose of study therapy
• •History of major surgery within 3 months or minor surgery within 1 month of the first dose of cabozantinib
• •Pregnant women