The pharmacological effects of using cabozantinib with a light breakfast

Phase 2

Recruiting

• Conditions: 10038364; kidney cancer; renal cell carcinoma

• Registration Number: NL-OMON53521
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

- 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 Criteria

- 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, delaviridine,
efavirenz, emtricitabine, benzbromarone and probenecid.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the increase of the area under the concentration-time<br /><br>curve (AUC) of the experimental regimen compared to the standard regimen. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoint is the analytical feasibility of microsampling<br /><br>(fingerprick) for future at home monitoring of cabozantinib exposure and the<br /><br>total number of patients experiencing (S)AEs.</p><br>