IRCI Gynae Sarcomas, High Grade Uterine Sarcoma

Exclusion Criteria

• •low-grade ESS, leiomyosarcoma (low or intermediate), carcinosarcoma, low-grade adenosarcoma, rhabdomyosarcoma (alveolar or embryonal) and soft tissue PNET of uterus/cervix.
• •contraindications to cabozantinib
• •not able to swallow and retain oral tablets
• •planned use of chemotherapy, radiation therapy, radionuclide treatment, small molecule tyrosine kinase inhibitor or hormonal therapy, and any other investigational agent (Cabozantinib/placebo) during the treatment period
• •concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment
• •patient with poorly controlled hypertension defined at baseline as blood pressure \>150/90
• •patients who have suffered a cerebrovascular accident at any time in the past, patients who have suffered a transient ischemic attack in the past 6 months, patients who have suffered a deep venous thrombosis (DVT) or a pulmonary embolism in the past 6 months
• •Gastrointestinal disorders
• •patients with radiographic evidence of cavitating pulmonary lesion(s)
• •patients with tumor in contact with, invading or encasing any major blood vessels
• •patients evidence of tumor invading the GI tract
• •evidence of active bleeding or bleeding diathesis
• •hemoptysis ≥ 0.5 teaspoon (2.5ml) of red blood within 3 months before the first dose of study treatment
• •signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment
• •clinically-significant gastrointestinal bleeding within 6 months before the first dose of study treatment
• •prior major surgery or trauma within 6 weeks prior to first dose of study drug and any wound, fracture, or ulcer should be completely healed
• •concurrent or planned treatment with strong inhibitors or inducers of cytochrome P450 3A4/5