Inclusion criteria | Exclusion criteria |
---|---|
• Signed written informed consent | • STS of uncertain differentiation (epithelioid, alveolar soft part, clear cell, desmoplastic small round cell, malignant mesenchymoma, PEComa), chondrosarcoma, Ewing sarcoma/PNET, chordoma, malignant solitary fibrous tumors, embryonal rhabdomyosarcoma, osteosarcoma, gastrointestinal stromal tumors, dermatofibrosarcoma protuberans, inflammatory myofibroblastic sarcoma (low grade), neuroblastoma, malignant mesothelioma, mixed mesodermal tumors of the uterus |
• Age ≥60 years | • Prior malignancy, except for subjects who have been disease-free for 2 years, or complete resection of nonmelanomatous skin carcinoma, or successfully treated in situ carcinoma or incidental prostate cancer (TNM stage T1a or T1b) |
• ECOG performance status of 0–2 | • History or clinical evidence of CNS metastases; previously treated subjects without signs of activity are allowed |
• Histologically confirmed diagnosis of metastatic or advanced STS of intermediate or high grade | • Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding or may affect absorption of IMP |
• Evidence of progressive disease within 6 months prior to study inclusion | • Presence of uncontrolled infection |
• Availability of archived tumor tissue of the most recent histology | • QTc >480 milliseconds using Bazett’s formula |
• Adequate organ system function as determined by laboratory assessment | • History of any of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, cerebrovascular accident (including TIA), pulmonary embolism, or untreated deep vein thrombosis |
• Adequate contraception for patients or partners with childbearing potential | • Class III or IV congestive heart failure as defined by the NYHA classification system |
• Negative pregnancy test for women of childbearing potential | • Poorly controlled hypertension |
• Major surgery or trauma within 28 days before first dose of IMP and/or presence of any nonhealing wound, fracture, or ulcer | |
• Evidence of active bleeding or bleeding diathesis | |
• Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels | |
• Hemoptysis in excess of 2.5 ml once within 8 weeks of first dose of IMP | |
• Any serious and/or unstable preexisting medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance with study procedures | |
• Unable or unwilling to discontinue use of prohibited medications for at least 14 days or 5 half-lives of a drug (whichever is longer) prior to the first dose of IMP and for the duration of the study | |
• Treatment with any anticancer therapies | |
• Any ongoing toxicity from prior anticancer therapy that is higher than CTCAE grade 1 and/or that is progressing in severity, except alopecia | |
• Prior systemic therapy for metastatic or advanced disease; neoadjuvant or adjuvant chemotherapy is allowed, unless disease progression occurred within 6 months following end of treatment | |
• Participation in any other clinical trial within 30 days before the study begins | |
• Known hypersensitivity to any component of IMPs |