The Effect of Hepatic Impairment on Outcomes in Phase I Clinical Trials in Cancer Subjects

Mansfield Aaron S.; Rudek Michelle A.; Vulih Diana; Smith Gary L.; Harris Pamela Jo; Ivy S. Percy

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The Effect of Hepatic Impairment on Outcomes in Phase I Clinical Trials in Cancer Subjects

机译：肝功能不全对癌症受试者I期临床试验结果的影响

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Purpose: The NCI Cancer Therapy Evaluation Program sponsors hepatic dysfunction phase I clinical trials (HDCT) and phase 1 clinical trials (P1CT) to determine safe doses and schedules of antineoplastic therapeutics. We sought to compare clinical outcomes between these trial types while stratifying by hepatotoxic agents.

机译：目的：NCI癌症治疗评估计划发起了肝功能障碍I期临床试验（HDCT）和1期临床试验（P1CT），以确定安全剂量和抗肿瘤治疗方案。我们试图比较这些试验类型之间的临床结局，同时按肝毒性药物进行分层。

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《Clinical cancer research: an official journal of the American Association for Cancer Research》 |2016年第22期|共8页
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Mansfield Aaron S.; Rudek Michelle A.; Vulih Diana; Smith Gary L.; Harris Pamela Jo; Ivy S. Percy;
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正文语种 eng
中图分类肿瘤学;
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1. The Effect of Hepatic Impairment on Outcomes in Phase I Clinical Trials in Cancer Subjects [J] . Mansfield Aaron S., Rudek Michelle A., Vulih Diana, Clinical cancer research: an official journal of the American Association for Cancer Research . 2016,第22期

机译：肝功能不全对癌症受试者I期临床试验结果的影响
2. A Phase 1, Open‐Label, Parallel‐Group, Single‐Dose Trial of the Pharmacokinetics and Safety of Cannabidiol (CBD) in Subjects With Mild to Severe Hepatic Impairment [J] . Taylor Lesley, Crockett Julie, Tayo Bola, The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology . 2019,第8期

机译：含有轻度至严重肝损伤的受试者的1期，开放标签，平行组，单剂量试验和Cannabidiol（CBD）的安全性和安全性
3. Phase II Trial of Hepatic Artery Infusional and Systemic Chemotherapy for Patients With Unresectable Hepatic Metastases From Colorectal Cancer Conversion to Resection and Long-term Outcomes [J] . DAngelica Michael I., Correa-Gallego Camilo, Paty Philip B., Annals of Surgery . 2015,第2期

机译：从结肠直肠癌转换为切除和长期结局的无法切除的肝转移患者的肝动脉灌注和全身化学治疗的II期试验
4. Clinical Trial of Liposome-Adriamycin (Lipo-ADR) via the Portal Vein and Hepatic Artery for Prophylaxis and Treatment after Hepatic Resection on Liver Metastasis in Advanced Gastric Cancer [C] . I. Mizuno, T. Yotsuyanagi, M. Ishida, International Gastric Cancer Congress . 2009

机译：脂质体 - 亚霉素（Lipo-ADR）通过门静脉和肝动脉进行预防和治疗治疗晚期胃癌肝转移后的临床试验
5. Clinical predictive value of pre-clinical cancer models: A study of the predictive value of the in vitro cell line, human xenograft and murine allograft pre-clinical cancer models for phase II clinical trials of cytotoxic cancer drugs [D] . Voskoglou-Nomikos, Theodora 2001

机译：临床前癌症模型的临床预测价值：体外细胞系，人异种移植和小鼠同种异体移植临床前癌症模型对细胞毒性癌症药物II期临床试验的预测价值研究
6. The effect of hepatic impairment on outcomes in phase 1 clinical trials in cancer subjects [O] . Aaron S. Mansfield, Michelle A. Rudek, Diana Vulih, -1

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7. Hepatic Resection Following Selective Internal Radiation Therapy for Colorectal Cancer Metastases in the FOXFIRE Clinical Trial: Clinical Outcomes and Distribution of Microspheres [O] . Helen Winter, Joseph Rassam, Pradeep S. Virdee, 2019

机译：肝切除术后肝脏临床试验中的结直肠癌转移后的肝切除：微球的临床结果和分布

The Effect of Hepatic Impairment on Outcomes in Phase I Clinical Trials in Cancer Subjects

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