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 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT02089802
Eligibility Criteria:
Inclusion Criteria:
* signature of informed consent
* age ≥ 18 years
* histologically confirmed renal cell carcinoma with clear cell component and either locally progressed or metastasized
* ECOG ≤ 2
* No previous systemic therapy for locally progressed or metastasized renal cell carcinoma (previous adjuvant or neo-adjuvant therapy is permitted)
* Adequate organ function
* Female patients with child-bearing potential with negative serum pregnancy test within 2 weeks prior to first dose of study medication and adequate contraception
* Lactating females
Exclusion Criteria:
* Clinically suspected and known metastases of the central nervous system or carcinomatous meningitis except in asymptomatic patients with previously treated CNS-metastases and no necessity of steroids or anti-epileptic medication ≥ 6 months prior to start of the study medication
* Clinically significant gastrointestinal conditions with risk of increase of gastrointestinal bleeding due to (but not limited to)
* active peptic ulceration
* known intraluminal metastases with risk of bleeding
* chronic-inflammatory intestinal disease (like Morbus Crohn, ulcerative colitis) or another gastrointestinal disease with increased risk of perforation
* abdominal fistulas in anamnesis
* Clinically significant gastrointestinal conditions which can influence absorption of the IMP, among others (but not limited to)
* malabsorption syndrome
* resection of stomach or small bowel
* Current uncontrolled infection
* QTc corrected for heart frequency according to the Bazett formula
* One or more of the following cardiovascular diseases within the last 6 months in the anamnesis:
* cardiac angioplasty or coronary stent implantation
* myocardial infarction
* instable angina pectoris
* coronary-arterial bypass surgery
* symptomatic peripheral arterial occlusive disease
* Heart failure NYHA III or IV
* Poorly controlled high blood pressure
* Cerebrovascular disease, including transitory ischemic attacks, pulmonary artery embolism or untreated deep vein thrombosis within 6 months of study inclusion
* Previous major surgery or traumas within 28 days prior to start if study treatment or non-healing wound, fracture or ulcer
* Clinical signs of active bleeding or bleeding diathesis
* Known endobronchial lesions or lesions infiltrating the large lung arteries
* Haemoptyses of \> 2.5 mL within 8 weeks prior to first intake of study medication
* Any other severe and/or instable medical or psychiatric pre-existing or other condition influencing patient safety, consent capacity or compliance within the study
* Incapacity or rejection to stop not allowed medication prior to first intake of study drug and pause for the duration of the trial
* Treatment with one of the following anti-tumour therapies:
* Radiation or tumour embolism within 14 days before first intake of study drug
* Chemotherapy, Immunotherapy, biological therapy, study medication or hormonal therapy within 14 days or 5 half-lives of the respective substance (whichever is longer) before first intake of the study drug. Neo-adjuvant or adjuvant therapy must have been completed for at least 6 months.
* Any present toxicity \> CTC 1° from prior anti-tumour therapy and/or toxicities worsening in severity except alopecia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02089802
Study Brief:
Protocol Section:
NCT02089802