Clinical TrialID 811
The Influence of Phenotype, Grapefruit Juice and Orange Juice on the Pharmacokinetics of Sunitinib in Cancer Patients
NCT01743300
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 811
- Evidence Id
- 811
- Core Evidence Id
- 811
- Source Clinical Trial Id
- 793
- Herb2 Clinical Trial Id
- HBCT000793
- Nct Id
- NCT01743300
- Title
- The Influence of Phenotype, Grapefruit Juice and Orange Juice on the Pharmacokinetics of Sunitinib in Cancer Patients
- Status
- Completed
- Phase
- Phase 1
- Study Result
- No
- Study Condition
- Healthy
- Study Type
- Interventional
- Study Design
- Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose:
- Intervention
- DRUG: Sunitinib|DRUG: Midazolam|OTHER: Orange juice|OTHER: Grapefruit juice
- Intervention Allocation
- Non_Randomized
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 15
- Outcome Measure
- The influence of grapefruit juice and orange juice on the steady state area under the curve (AUC) of sunitinib in cancer patients, Subjects will receive sunitinib in the registered schedule of 4 weeks "on" (28 days) 2 weeks "off" (14 days).Sunitinib steady state is reached after 14 days. Additionally patients receive grapefruit juice on day 25-27 of treatment. To determine the influence of grapefruit juice, sunitinib pharmacokinetics (PK) will be assessed on PK day 1, which will be between treatment day 14-20 (without grapefruit juice) and on PK day 2 on day 28 of treatment (after taking grapefruit juice for 3 days)., Patients will be included for 42 days into the study. Within these 42 days, 3 PK measuring days are planned (see also description)|The feasibility of midazolam as a phenotyping probe for sunitinib exposure (area under concentration time curve)in cancer patients, Subjects will receive sunitinib in the registered schedule of 4 weeks "on" (28 days) 2 weeks "off" (14 days).Sunitinib steady state is reached after 14 days. To determine the feasibility of midazolam as a phenotyping probe, sunitinib PK from PK day 1, which is between treatment day 14-20 and the PK of midazolam from PK day 3 on day 42 of treatment (the end of the wash out period of sunitinib) will be determined., Patients will be included for 42 days into the study. Within these 42 days, 3 PK measuring days are planned (see also description)
- Sponsor Collaborator
- Leiden University Medical Center
- Funded By
- OTHER
- Location
- Other Id
- P07.111
- Start Date
- 2007-07
- Primary Completion Date
- 2010-12
- Completion Date
- 2010-12
- First Posted
- 2012-12-06
- Results First Posted
- Last Update Posted
- 2012-12-19
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT01743300
- Title Cn
- Title En
- The Influence of Phenotype, Grapefruit Juice and Orange Juice on the Pharmacokinetics of Sunitinib in Cancer Patients
- Bilingual Status
- semi_complete