Phase II Study of Regorafenib as Maintenance Therapy

Exclusion Criteria

• •Prior adjuvant or neoadjuvant chemotherapy not allowing at least 6 cycles of doxorubicin-based chemotherapy at metastatic stage
• •Complete response to 1st line chemotherapy for metastatic/locally advanced soft tissue sarcoma
• •Disease progression during the 1st line of chemotherapy
• •Time interval between the last cycle of doxorubicin-based chemotherapy superior to 8 weeks
• •Primary bone sarcoma
• •All forms of liposarcoma
• •Some particular histologic types, i.e., PNET/Ewing, alveolar or embryonal rhabdomyosarcoma, Perivascular epithelioid cell sarcoma (PECoMA), low grade endometrial stromal tumor, desmoid tumor
• •Prior treatment with tyrosine kinase inhibitor
• •Known history of or concomitant malignancy likely to affect life expectancy in the judgment of the investigator
• •Pregnant or breastfeeding patients. Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of treatment
• •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of Day 1 of treatment
• •Active cardiac disease including any of the following: Congestive heart failure (New York Heart Association \[NYHA\]) ≥Class 2, Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months), Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
• •Uncontrolled hypertension (Systolic blood pressure \>150 mmHg or diastolic pressure \>90 mmHg despite optimal medical management)
• •Arterial or venous thrombotic or embolic events such as myocardial infarction, cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within 6 months of starting on study drug
• •Any hemorrhage or bleeding event \> Grade 4 within 4 weeks of start of treatment
• •Ongoing infection \>Grade 2 according to NCI Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v. 5.0)
• •Known history of human immunodeficiency virus (HIV) infection
• •Known history of chronic hepatitis B or C
• •Patients with seizure disorder requiring medication
• •History of organ allograft
• •Evidence or history of bleeding diathesis. Any hemorrhage or bleeding event \> Grade 4 within 4 weeks of start of treatment
• •Non-healing wound, ulcer, or bone fracture
• •Renal failure requiring hemo- or peritoneal dialysis
• •Dehydration according to NCI-CTC v 4.0 Grade \>1
• •Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
• •Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation
• •Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
• •Inability to swallow oral medications, Any mal-absorption condition
• •Pleural effusion or ascites that causes respiratory compromise (Grade 2 dyspnea)