Clinical trial NCT02089802 (phase 2, status: terminated)
Conditions: locally advanced renal cell carcinoma, metastatic renal cell carcinoma
ICD codes: C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8
Drugs: pazopanib
SMILES: ClCCN(CCCl)P1(=O)NCCCO1
Reason stopped: 
    early termination due to lack of recruitment
  
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