Renal cell carcinoma
Conditions
Interventions
Trade Name: Votrient 200 mg
Product Name: Pazopanib
Product Code: GW786034
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PAZOPANIB HYDROCHLORIDE
CAS Number: 635702-64-6
Concentration un
Sponsors
Interessenverband zur Qualitätsicherung der Arbeit niedergelassener Uro-Onkologen in Deutschland (IQUO) e.V.
Eligibility
Sex/Gender
All
Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: - Clinically suspected and known metastases of the central nervous system or meningeosis carcinomatosis 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, colitis ulcerosa) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine if in patients with a Pazopanib plasma trough level of = 20 µg/mL a plasma trough level of > 20 =g/mL can be achieved by dose escalation. ;Primary end point(s): Fraction of LPLPs who achieve a plasma trough level of > 20 µg/mL by dose optimization.;Secondary Objective: - Comparison of patients with normal Pazopanib plasma trough levels (“normal plasma level patients; NPLP) with patients with low Pazopanib plasma trough levels (“Low plasma level patients”; LPLP) with regard to the therapeutic result: - objective remission rate - progression free survival - overall survival - comparison of LPLP in whom the plasma trough level could be optimized successfully and LPLP in whom the plasma trough level could not be optimized with regard to above parameters - Correlation of plasma trough levels and side effects, especially high blood pressure - Correlation of the occurrence of high blood pressure with oncological result (response rate) - Recording of demographic data, compliance, concomitant medication, and correlation with plasma trough levels (LPLP / NPLP) - Examination of life quaility;Timepoint(s) of evaluation of this end point: 14 days after treatment start and 14 days after each dose optimization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 30 days after the last patient completed study treatment.;Secondary end point(s): - Objective response rate, defined as complete or partial remission lasting = 4 weeks (determined according to RECIST criteria version 1.1) - Progression free survival, defined as the time between study registration and disease progression (determined according to RECIST criteria version 1.1) or death during the study (defined as death during treatment or within 30 days after end of treatment) - Overall survival, defined as the time between study registration until death (for any reason) - Descriptive comparison of the therapeutic response (objective response rate, progression free survival, overall survival) of LPL and NPL patients - Correlation of plasma trough level and side effects, especially high blood pressure - Correlation of the occurrence of high blood pressure with therapeutic response - Recording of demographic data, compliance, concomitant medication and correlation with plasma trough levels - Examination of life quality, measured by EQ-5D | — |
Countries
Germany
Contacts
Public ContactCRO - Clinical Research Organisatio
OnkoDataMed GmbH
Outcome results
None listed