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Table 1 Inclusion and exclusion criteria

From: A phase II trial comparing pazopanib with doxorubicin as first-line treatment in elderly patients with metastatic or advanced soft tissue sarcoma (EPAZ): study protocol for a randomized controlled trial

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
  1. Abbreviations: CTCAE Common Terminology Criteria for Adverse Events, ECOG Eastern Cooperative Oncology Group, IMP investigational medical product, NYHA New York Heart Association, PEComa perivascular epithelioid cell tumor, PNET primitive neuroectodermal tumor, QTc corrected QT interval, STS soft tissue sarcomas, TIA transient ischemic attack