renal cell carcinoma
Conditions
Interventions
None listed
Sponsors
Apotheek
Eligibility
Age
18 Years to 99 Years
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. 2) * 18 year old men and women who use pazopanib 3) Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Exclusion criteria
Exclusion criteria: 1) Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, 2) Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject*s safety, provision of informed consent, or compliance to study procedures. 3) Unable or unwilling to discontinue use of prohibited medications 4) Concurrent use of other substances known or likely to interfere with the pharmacokinetics of pazopanib.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A The aim of this part of the study is to determine the equivalent reduced dose of pazopanib when taken with a continental breakfast compared to the registered intake of pazopanib (e.g. 800 mg OD without food) Part B The aim of this part of the study is to show a decrease of the side effects, diarrhea and nausea when an pazopanib is taken with food. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A To explore, quantify and describe the correlation in the occurrence of side effects when pazopanib is taken with food. Part B To explore, quantify and describe patients preference; pazopanib intake with or without food. To explore the progression free survival of the total cohort of the patients and to compare this against historical data. | — |
Countries
Netherlands
Outcome results
None listed