Patients who are treated or will be treated with pazopanib. MedDRA version: 19.0 Level: PT Classification code 10067946 Term: Renal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.0 Level: LLT Classification code 10073145 Term: Soft tissue cancer Syst
Conditions
Interventions
Trade Name: Votrient
Pharmaceutical Form:
Sponsors
Radboud University Nijmegen Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-up. Note: Informed consent may be obtained prior to start of the specified screening window. 1) = 18 year old men and women who use pazopanib for soft tissue sarcoma or metastatic renal cell carcinoma 2) Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 3) BMI between 18-30 kg/m2 4) Adequate organ system function bsolute neutrophil count (ANC) >1.5 X 109/L Hemoglobina >9 g/dL (5.6 mmol/L) Platelets >100 X 109/L Total bilirubin 1.5 mg/dL: Calculated creatinine clearance (ClCR) >30 mL/min Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 19
Exclusion criteria
Exclusion criteria: 1) Poorly controlled hypertension; systolic blood pressure = 40 mm Hg or diastolic blood pressure = 90 mm Hg. Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. Following antihypertensive medication initiation or adjustment, blood pressure (BP) must be re-assessed three times at approximately 2-minute intervals. At least 24 hours must have elapsed between anti-hypertensive medication initiation or adjustment and BP measurement. These three values should be averaged to obtain the mean diastolic blood pressure and the mean systolic blood pressure. The mean SBP / DBP ratio must be 480msecs. 3) History of any one or more 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 • Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) 4) Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to: • Active peptic ulcer disease. • Known intraluminal metastatic lesion/s with risk of bleeding. • Inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease), or other gastrointestinal conditions with increased risk of perforation. • History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment. 5) Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to: • Malabsorption syndrome. • Major resection of the stomach or small bowel. 6) History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible. 7) Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major surgery). 8) Evidence of active bleeding or bleeding diathesis. 9) Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage. Note: Lesions infiltrating major pulmonary vessels (contiguous tumor and vessels) are excluded; however, the presence of a tumor that is touching, but not infiltrating (abutting) the vessels is acceptable (CT with contrast is strongly recommended to evaluate such lesions). 10) Recent hemoptysis (?½ teaspoon of red blood within 8 weeks before first dose of study drug). 11) Any serious and/or unstable pre-existing medical, psychiatric
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Part A: The aim of this study to show that a dose reduction of pazopanib is possible when ingested with a regular continental breakfast to maintain equivalent AUC compared to 800 mg pazopanib ingested in a fasted state. Part B: The aim of this study is to show a difference is the occurrence of side effects (e.g. diarrhea and nausea) when a reduced dose of pazopanib is ingested with food. ; Main Objective: Part A: To determine the equivalent dose of pazopanib when taken with a continental breakfast compared to 800 mg in fasted state. Part B:To evaluate whether food can reduce the side effects diarrhea and nausea. ; Secondary Objective: Part A: To monitor the occurrence of adverse events of pazopanib with and without food according to the CTC-AE criteria v 4.03. Part B: To evaluate the preference of the patients: intake of pazopanib with or without food. ; Timepoint(s) of evaluation of this end point: Part A: after trial day 29 Part B: after trial day 61 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Part A: To explore, quantify and describe the correlation in the occurrence of side effects when pazopanib is ingested with food. Part B: To explore, quantify and describe the correlation in patients own preference between ingesting pazopanib with and without food. ; Timepoint(s) of evaluation of this end point: Part A: after trial day 29 Part B: after trial day 61 | — |
Countries
Netherlands
Contacts
Public ContactAngela Colbers
Radboud University Nijmegen Medical Centre
Outcome results
None listed