2026-525267-40-00招募中4 期
Intensified Monitoring of PhArmacology of Cabozantinib as a tool for Toxicity management in patients with renal cell carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- The impact of the counseling intervention on Cabozantinib related toxicity will be evaluated as the overall reduction of the frequency of treatment interruptions due to clinically relevant toxicity in RCC patients treated with Cabozantinib, compared to historical data.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients with non-renal cell neoplasms of the kidney (e.g. urothelial, sarcoma, lymphoma).
- •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.
- •Pregnancy status.
- •Refusal of informed consent.
- •Patients who could not attend periodic clinical check-ups.
- •Any condition that, in the investigator’s judgment, could compromise appropriate participation in the study.
研究组 & 干预措施
Cabozantinib Ipsen 20 mg film-coated tablets, Cabozantinib Ipsen 40 mg film-coated tablets, OPDIVO 10 mg/mL concentrate for solution for infusion., Cabozantinib Ipsen 60 mg film-coated tablets
Test
干预措施: Cabozantinib Ipsen 40 mg film-coated tablets (Drug)
Cabozantinib Ipsen 20 mg film-coated tablets, Cabozantinib Ipsen 40 mg film-coated tablets, OPDIVO 10 mg/mL concentrate for solution for infusion., Cabozantinib Ipsen 60 mg film-coated tablets
Test
干预措施: Cabozantinib Ipsen 20 mg film-coated tablets (Drug)
Cabozantinib Ipsen 20 mg film-coated tablets, Cabozantinib Ipsen 40 mg film-coated tablets, OPDIVO 10 mg/mL concentrate for solution for infusion., Cabozantinib Ipsen 60 mg film-coated tablets
Test
干预措施: OPDIVO 10 mg/mL concentrate for solution for infusion. (Drug)
Cabozantinib Ipsen 20 mg film-coated tablets, Cabozantinib Ipsen 40 mg film-coated tablets, OPDIVO 10 mg/mL concentrate for solution for infusion., Cabozantinib Ipsen 60 mg film-coated tablets
Test
干预措施: Cabozantinib Ipsen 60 mg film-coated tablets (Drug)
结局指标
主要结局
The impact of the counseling intervention on Cabozantinib related toxicity will be evaluated as the overall reduction of the frequency of treatment interruptions due to clinically relevant toxicity in RCC patients treated with Cabozantinib, compared to historical data.
The impact of the counseling intervention on Cabozantinib related toxicity will be evaluated as the overall reduction of the frequency of treatment interruptions due to clinically relevant toxicity in RCC patients treated with Cabozantinib, compared to historical data.
次要结局
- Inflammatory marker levels according to incidence/severity of adverse events.
- Mean/median values over time.
- Mean/median difference in ctDNA levels according to disease progression/response.
- Absolute and relative frequencies.
- Predictive performance of model-based vs. log-linear extrapolation TDM approaches.
- Linear regression coefficient with relative 95% CI.
- Incidence/severity of treatment-related adverse events according to genetic variants.
- Mean/median Cmin difference according to inflammatory marker levels.
- Rate of adherence to pharmacological counseling recommendations.
- Analytical performance parameters (accuracy, precision, linearity, LLOQ, stability).
- Analytical performance parameters (accuracy, precision, linearity, LLOQ, stability). Comparability with LC-MS method.
- Sensitivity and specificity of Cmin cut-off values for predicting adverse events.
- Mean/median Cmin difference according to genetic variants.
研究者
Erika Cecchin
Scientific
Centro Di Riferimento Oncologico Di Aviano
研究点 (2)
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