The Influence of Phenotype, Grapefruit Juice and Orange Juice on the Pharmacokinetics of Sunitinib in Cancer Patients

PHASE1CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

December 31, 2010

Study Completion Date

December 31, 2010

Conditions
Healthy
Interventions
DRUG

Sunitinib

All patients receive once daily 50 mg sunitinib for 6 weeks in the registered schedule of 4 weeks on two weeks off treatment.

DRUG

Midazolam

All patients receive three times midazolam 7,5 mg on PK day 1,2, and 3 e.g. between day 14-21 of treatment, on day 28 of treatment and on day 42 of treatment.

OTHER

Orange juice

The orange juice will be administered 3 times per day for 1 period of 3 days in the 4th week of treatment with sunitinib, just before PK day 2 on day 28 of treatment

OTHER

Grapefruit juice

The grapefruit juice will be administered 3 times per day for 1 period of 3 days in the 4th week of treatment with sunitinib, just before PK day 2 on day 28 of treatment

All Listed Sponsors
lead

Leiden University Medical Center

OTHER

NCT01743300 - The Influence of Phenotype, Grapefruit Juice and Orange Juice on the Pharmacokinetics of Sunitinib in Cancer Patients | Biotech Hunter | Biotech Hunter