Sorafenib administered using a high-dose, pulsatile regimen in patients with advanced solid malignancies: a phase I exposure escalation study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
Honeywell R, Yarzadah K, Giovannetti E, et al. Simple and selective method for the determination of various tyrosine kinase inhibitors used in the clinical setting by liquid chromatography tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2010;878:1059-68.
-Pécuchet N, Lebbe C, Mir O, et al. Sorafenib in advanced melanoma: a critical role for pharmacokinetics? Br J Cancer. 2012;107:455-61.
-Strumberg D, Clark JW, Awada A, et al. Safety, pharmacokinetics, and preliminary antitumor activity of sorafenib: a review of four phase I trials in patients with advanced refractory solid tumors. Oncologist. 2007;12:426-37.
-Wang X, Zhang L, Goldberg SN, et al. High dose intermittent sorafenib shows improved efficacy over conventional continuous dose in renal cell carcinoma. J Transl Med. 2011;9:220. doi: 10.1186/1479-5876220.
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Histological or cytological documentation of incurable locally advanced or metastatic solid malignancy for which no standard therapy exists.
- •2. Patients eligible for the expansion cohort must be willing to undergo tumor and skin biopsies, while tumor and skin biopsies are optional for patients enrolled in the escalation cohort. Primary tumor or metastatic site must be accessible for biopsy. Bone metastases are excluded as a biopsy site.
排除标准
- •1. Evidence of a significant uncontrolled concomitant disease, such as cardiovascular disease (including stroke, New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to screening, unstable arrhythmia, clinically significant valvular heart disease and unstable angina); nervous system, pulmonary (including obstructive pulmonary disease and history of symptomatic bronchospasm), renal, hepatic, endocrine, or gastrointestinal disorders; or a serious non-healing wound or fracture.
- •2. Prior radiotherapy in the abdominal or thoracic area or in > 3 vertebrae in the spine (if long interval since previous radiotherapy or radiotherapy in ¡Ü 3 vertebrae, eligibility will be decided on an individual basis by the primary investigator).