Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 12:20 AM
NCT ID:
NCT03735758
Eligibility Criteria:
Inclusion Criteria:
* The informed consent form must be signed before any study specific tests or procedures are done
* Male or female patients aged 18 years and older at the first screening visit
* Histologically confirmed diagnosis of advanced or metastatic non adipocyte soft tissue sarcoma (STS)
* Suitable for treatment with pazopanib in an in-label prescription
* Patients with a life expectancy of at least 6 months
* Eastern Co-operative Oncology Group (ECOG) performance status 0-2
* Adequate organ function as given in Table 1
* For patients with previous anthracycline therapy a normal heart function needs to be documented with an left ventricular ejection fraction (LVEF) of minimal 50% (echocardiogram)
* Patients must be willing and able to fill in the Quality of live (QoL) questionnaires using a tablet PC
* Ability to understand and follow study-related instructions
* Confirmation of the subject's health insurance coverage prior to the first visit
Exclusion Criteria:
* Pretreatment with pazopanib
* Contraindications according to the local Summary of product characteristics ( SmPC) of Votrient®
* Patients having to following STS specific tumors
* adipocyte sarcoma including all subtypes,
* all rhabdomyosarcoma, which are not alveolar or pleomorph
* Chondrosarcoma
* Osteosarcoma
* Ewing-tumors, i.e. primitive neuroectodermal tumors (PNET), gastrointestinal stromal tumor (GIST)
* Dermatofibrosarcoma protuberans
* inflammatory myofibroblastic sarcoma
* Malignant mesothelioma
* Mixed mesenchymal and epidermal tumors of the uterus Other malignant underlying diseases with the exception of the following:
* Free of disease for at least 3 years
* Completely resected, non-melanoma skin cancer
* Successfully treated carcinoma in situ
* Patients with metastases of the central nervous system (CNS) at screening, which are asymptomatic AND do not require treatment with steroids or enzyme-inducing anticonvulsant drugs
* Patients with metastases of the CNS, which are already treated (operation and/or radiotherapy, radiosurgery or gamma-knife)
* Major surgery or trauma within 28 days before the first dose of study medication and / or presence of a non-healing wound, fracture, or ulcer
* Clinical indications of an active bleeding or a bleeding diathesis
* Known endobronchial lesions or lesions that infiltrate the large pulmonary artery
* Hemoptysis of\> 2.5 mL within 8 weeks before the first dose of study drug
* Existing uncontrolled infection
* Heart rate-corrected QT-time according to the Fridericia's-formula (QTcF) 450 ms in males and 460 ms in females
* History of one or more of the following cardiovascular diseases within the last 6 months:
* Cardiac angioplasty or coronary stent
* Myocardial infarction
* Unstable angina pectoris
* Coronary artery bypass surgery
* Symptomatic peripheral arterial disease
* Cardiac insufficiency New York Heart Association (NYHA) functional dass III or IV
* Poorly controlled hypertension defined as systolic blood pressure 140 mmHg or diastolic blood pressure 90 mmHg
* History of cerebrovascular disease, including transient ischemic attacks (TIA), pulmonary embolism or untreated deep vein thrombosis within 6 months prior to study entry. Patients with deep vein thrombosis who have received therapeutic anticoagulation for a minimum of 6 weeks might be included in the study.
* Clinically significant gastrointestinal changes that increase the risk of gastrointestinal bleeding
* Clinically significant gastrointestinal changes that may affect the absorption of the study drugs
* Treatment with any of the following anti-neoplastic therapies:
* Irradiation or Tumor embolization within 14 days prior to the first dose of study drug
* Chemotherapy, immunotherapy, biological therapy, study medication or hormonal therapy within 14 days or 5 half lives of substance (whichever is langer) prior to the first dose of study drug
* If the discontinuation of prohibited medication (see Section 6.9) at least 14 days or 5 half-lives of substance (whichever is langer) prior to the first dose of pazopanib is medically not acceptable or refused by the patient
* A history of hypersensitivity to any of the study drugs or their ingredients or to drugs with similar chemical structure
* Addiction or other diseases that preclude the patient from appropriately assessing the nature and scope as well as possible consequences of the clinical trial
* Pregnant or breast-feeding women
* Women of childbearing potential unless women who meet the following criteria:
* Post-menopausal (12 months natural amenorrhea without any application of a hormonal contraceptive or hormonal substitution therapy))
* Postoperatively (6 weeks after bilateral ovariectomy with or without hysterectomy)
* Regular and correct use of a contraceptive method with error rate \<1% per year such as implants, depot injections, oral contraceptives or intrauterine devices during treatment and up 6 months after end of treatment
* Sexual abstinence
* Vasectomy of the partner
* Men of sexual activity with women of childbearing potential who are not willing to use an effective barrier method of contraception during and up to 6 months after the end of therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03735758
Study Brief:
Protocol Section:
NCT03735758