Intensified Monitoring of PhArmacology of Cabozantinib as a tool for Toxicity management in patients with renal cell carcinoma
Key facts
- Where
- Aviano és Bolzano, OlaszországSee the 2 sites
- Phase
- 4. fázis
Where in Olaszország
- Centro di Riferimento Oncologico di AvianoAviano, OlaszországTaking people
- Azienda Sanitaria Dell'Alto AdigeBolzano, OlaszországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centro Di Riferimento Oncologico Di Aviano
- Trial code
- EU 2026-525267-40-00
- Record updated
- 2026. május 21.
- Original description
To evaluate whether the implementation of a systematic pharmacological counseling activity based on TDM, pharmacogenetics and pharmacological interaction analysis, providing cabozantinib treatment-management suggestions to prescribing oncologists, results in a reduced frequency of treatment interruptions due to clinically relevant Cabozantinib-related toxicity in RCC patients compared with historical data.Read full original descriptionShow less
To evaluate whether the implementation of a systematic pharmacological counseling activity based on TDM, pharmacogenetics and pharmacological interaction analysis, providing cabozantinib treatment-management suggestions to prescribing oncologists, results in a reduced frequency of treatment interruptions due to clinically relevant Cabozantinib-related toxicity in RCC patients compared with historical data.
Inclusion: Patients diagnosed with histologically confirmed advanced/metastatic RCC with predominantly clear-cell subtype; Patients will be included in the study regardless of their time of treatment start with cabozantinib and regardless of their concomitant diseases or co-medication; Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC, candidate to receive systemic treatment with Nivolumab + Cabozantinib or Cabozantinib monotherapy as per clinical practice (investigators choice); Signed Written Informed Consent; Male or female subjects aged ≥18 years old; Women of childbearing potential must avoid pregnancy while on Cabozantinib. Female partners of male patients taking cabozantinib must also avoid pregnancy. Effective methods of contraception should be used by male and female patients and their partners during therapy, and for at least 4 months after completing therapy. Because oral contraceptives might possibly not be considered as “effective methods of contraception”, they should be used together with another method, such as a barrier method; Previous nephrectomy is permitted; All IMDC (International Metastatic RCC Database Consortium) risk (good, intermediate, poor); Eastern Cooperative Oncology Group performance status 0 or 1; Capable of understanding and complying with the protocol requirements.
Exclusion: Diagnosis of any non-RCC malignancy occurring within 2 years prior to the date of the start of treatment except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix or low-grade prostate cancer (≤pT2, N0; Gleason 6) with no plans for treatment intervention; Any condition that, in the investigator’s judgment, could compromise appropriate participation in the study; Patients with non-renal cell neoplasms of the kidney (e.g. urothelial, sarcoma, lymphoma); Pregnancy status; Refusal of informed consent; Patients who could not attend periodic clinical check-ups.