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【drug-news】因临床问题，礼来停止了黑色素瘤的
Eli Lilly has suffered a setback with the news that it has stopped a late-stage clinical trial of its investigational skin cancer drug tasis*** after 12 study participants died.
The company has suspended its global Phase III study evaluating tasis*** as a second-line treatment for patients with unresectable or metastatic melanoma. Lilly, in consultation with an independent data monitoring committee, has recommended a "full clinical hold," because of safety concerns. The trial sought to compare tasis*** versus paclitaxel and enrolled more than 300 patients in 18 countries; its primary endpoint is overall survival.
Now the company is going to see whether the 12 deaths are in any way related to treatment with tasis***. Richard Gaynor, head of oncology product development and medical affairs for Lilly, said “we are thoroughly reviewing the clinical trial data to understand what modifications to the study protocol or dosing would be needed to improve patient safety on this trial”.
Lilly will continue to develop tasis*** “across a wide range of tumours”, including soft tissue sarcoma, breast, ovarian and renal cancers, as well as non-small cell lung cancer and acute leukaemia. The firm added that these studies are not being modified because the dosing of tasis*** is different but it is “closely evaluating patient safety within these trials on an ongoing basis”.
Tasis*** was granted orphan drug status for stage 2b-IV melanoma by the US Food and Drug Administration in late 2009.
http://www.pharmatimes.com/Article/10-12-15/Lilly_suspends_melanoma_trial_after_deaths.aspx 试试翻译，48小时内未提交，请其他战友认领。 Lilly suspends melanoma trial after deaths
在部分受试者死亡情况下，礼来暂停其黑素瘤临床试验
Eli Lilly has suffered a setback with the news that it has stopped a late-stage clinical trial of its investigational skin cancer drug tasis*** after 12 study participants died.
礼来正在因为一个消息而经受挫折，在其皮肤癌药物tasis***临床试验中，由于12例受试者死亡，而暂停了其已进入后期的临床试验。
The company has suspended its global Phase III study evaluating tasis*** as a second-line treatment for patients with unresectable or metastatic melanoma. Lilly, in consultation with an independent data monitoring committee, has recommended a "full clinical hold," because of safety concerns. The trial sought to compare tasis*** versus paclitaxel and enrolled more than 300 patients in 18 countries; its primary endpoint is overall survival.
公司暂停了tasis***作为二线治疗不可切除或转移性黑素瘤的全球III期临床试验。礼来在与独立数据监查委员会磋商后，因为安全性问题，做出了试验全面暂停的决定。这项试验的目的是与紫杉醇作为比较，在18个国家已招募了300多名受试者，终点指标为总生存数。
Now the company is going to see whether the 12 deaths are in any way related to treatment with tasis***. Richard Gaynor, head of oncology product development and medical affairs for Lilly, said “we are thoroughly reviewing the clinical trial data to understand what modifications to the study protocol or dosing would be needed to improve patient safety on this trial”.
现在，公司正在调查这12例受试者的死亡是否与tasis***治疗有关。Richard Gaynor,礼来首席肿瘤药物和医学事务科学家表示，“我们正在重新审查这些临床数据，已明确怎样修改实验方案或计量，已便改善本实验的安全性”。
Lilly will continue to develop tasis*** “across a wide range of tumours”, including soft tissue sarcoma, breast, ovarian and renal cancers, as well as non-small cell lung cancer and acute leukaemia. The firm added that these studies are not being modified because the dosing of tasis*** is different but it is “closely evaluating patient safety within these trials on an ongoing basis”.
礼来将继续研发tasis***在“大范围肿瘤”方面的研发，包括软组织肉瘤、乳腺、卵巢和肾癌、也包括非小细胞肺癌和急性白血病。公司还表示这些试验的剂量不需改变，因为这些试验的剂量时不同的，但是这些试验的受试者安全性评估正在进行。
Tasis*** was granted orphan drug status for stage 2b-IV melanoma by the US Food and Drug Administration in late 2009.
Tasis***在2009年被FDA作为孤儿药批准IIb-IV期临床试验。
汇总：
在部分受试者死亡情况下，礼来暂停其黑素瘤临床试验
礼来正在因为一个消息而经受挫折，在其皮肤癌药物tasis***临床试验中，由于12例受试者死亡，而暂停了其已进入后期的临床试验。
公司暂停了tasis***作为二线治疗不可切除或转移性黑素瘤的全球III期临床试验。礼来在与独立数据监查委员会磋商后，因为安全性问题，做出了试验全面暂停的决定。这项试验的目的是与紫杉醇作为比较，在18个国家已招募了300多名受试者，终点指标为总生存数。
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作者:admin@医学,生命科学 2010-12-24 21:22
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