The influence of probenecid on the metabolism of sorafenib
Completed
- Conditions
- Hepatocellular carcinomathyroid carcinomarenal cell carcinoma HCC, hepatocellulair carcinoomRCC, NiercelcarcinoomSchildkliercarcinoom
- Registration Number
- NL-OMON21261
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
Inclusion Criteria
1. Age ≥ 18 years
2. Histological or cytological confirmed diagnosis of mRCC, HCC or differentiated thyroid carcinoma
Exclusion Criteria
1. Use of drugs which may show an increased systemic exposure when taken concomitantly with probenecid. (see appendix C)
2. Patients with known blood dyscrasias, uric acid kidney stones or until an acute gouty attack has subsided.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate bioequivalence of sorafenib with probenecid relative to sorafenib without probenecid based on the AUC in patients with unresectable hepatocellular cancer, advanced clear-cell renal cell carcinoma, locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment.
- Secondary Outcome Measures
Name Time Method 1. Other pharmacokinetic outcomes (i.e. clearance, maximum concentration (Cmax), Maximum steady-state concentration (Cmaxss), Minimal concentration (Cmin), steady-state volume of distribution (Vss) and half-life (t½)).<br /><br>2. To evaluate the incidence and severity of side-effects of treatment with sorafenib in absence and presence of probenecid (in particular HFSR) .<br /><br>3. To evaluate the intracellular concentration of sorafenib in skin in patients treated with sorafenib in absence and presence of probenecid.<br /><br>4. To determine the influence of HFSR on quality of life