Status:
COMPLETED
The Pharmacological Effects of Using Cabozantinib With a Light Breakfast
Lead Sponsor:
dr. Tom van der Hulle
Collaborating Sponsors:
Leiden University Medical Center
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Cabozantinib is a drug which is used to treat metastasized kidney cancer. While it works well, it has a lot of side effects and is quite expensive (€213,- every tablet, €6403,- every month). The stand...
Eligibility Criteria
Inclusion
- Willing and able to provide informed consent;
- Aged 18 years or older;
- Histologically confirmed advanced renal cell carcinoma;
- Receiving cabozantinib as monotherapy as treatment for RCC;
- At least 4 weeks on a stable dosage of cabozantinib;
- Acceptable tolerability and the need for dose reductions or treatment interruptions has been estimated as low;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- Estimated life expectancy of ≥ 6 months;
- No response evaluation planned during the study period;
- Cabozantinib trough concentration ≤1125 ng/ml in steady state
Exclusion
- Inability to follow the recommended light breakfast;
- Gastro-intestinal abnormalities influencing the absorption of cabozantinib, including active inflammatory bowel diseases, malabsorption syndrome and prior major surgery of the stomach, pancreas, liver or smaller bowel.
- Use of moderate or strong inhibitor of cytochrome P450 enzymes within 1 month of start of treatment with cabozantinib, including ketoconazole, grape fruit juice, clarithromycin, erythromycin, itraconazole and ritonavir.
- Use of moderate or strong inducer of cytochrome P450 enzymes within 1 month of start of treatment with cabozantinib, including rifampicin, phenytoin, carbamazepine, phenobarbital and herbal preparations containing St. John's Wort.
- Use of inhibitor of multidrug resistance-associated protein 2 within 1 month of start of treatment with cabozantinib, including cyclosporine, delavirdine, efavirenz, emtricitabine, benzbromarone and probenecid.
Key Trial Info
Start Date :
May 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05263245
Start Date
May 25 2023
End Date
March 11 2025
Last Update
September 3 2025
Active Locations (2)
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1
Leids Universitair Medisch Centrum
Leiden, South Holland, Netherlands, 2333 ZA
2
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015 GD