NL-OMON53521招募中2 期
The pharmacological effects of using cabozantinib with a light breakfast - Skippy 1 study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- 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
排除标准
- •- 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.
研究者
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