INHIBITOR: Retrospective Study Of Patients With Renal Cell Carcinoma And Mantle Cell Lymphoma Treated With Temsirolimus
2016年3月25日 更新者：Pfizer
Inhibitor - Estudio Retrospectivo De Casos Clinicos De Pacientes Con Carcinoma De Celulas Renales Y Con Linforma De Celulas Del Manto Tratados Con Temsirolimus
The principal objective of the study is to evaluate the efficacy and safety of temsirolimus use in patients with Renal Cell Carcinoma and Mantle Cell Lymphoma.
研究概览
详细说明
There is not sampling method
研究类型
观察性的
注册 (实际的)
243
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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A Coruña、西班牙、15006
- Complexo Hospitalario Universitario A Coruña
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Avila、西班牙、05004
- Complejo AAsistencial de Avilla
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Barcelona、西班牙、08035
- Hospital Vall d'hebrón
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Barcelona、西班牙、08025
- Hospital de La Santa Creu i Sant Pau
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Barcelona、西班牙、8940
- Hospital Del Mar
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La Coruña、西班牙、15006
- Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera
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Madrid、西班牙、28046
- Hospital Universitario La Paz
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Madrid、西班牙、28007
- Hospital General Universitario Gregorio Marañón
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Madrid、西班牙、28033
- MD Anderson Cancer Center
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Madrid、西班牙、28050
- Hospital de Madrid Norte - Sanchinarro
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Asturias
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Oviedo、Asturias、西班牙、33006
- Hospital Universitario Central de Asturias
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Gijon
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Cabueñes、Gijon、西班牙、33394
- Hospital de Cabueñes
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La Coruña
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Santiago de Compostela、La Coruña、西班牙、15706
- Hospital Clinico Universitario
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Las Palmas
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Las Palmas de Gran Canaria、Las Palmas、西班牙、35016
- Complejo Hospitalario Materno-Infantil Insular de Las Palmas
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Navarra
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Pamplona、Navarra、西班牙、31008
- Hospital de Navarra
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Valencia
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Castellon、Valencia、西班牙、12002
- Hospital Provincial de Castellon
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients with Renal Cell Carcinoma or Mantle Cell Lymphoma that have been treated with Temsirolimus as per clinical practice.
描述
Inclusion Criteria:
Patients with Renal Cell Carcinoma or Mantle Cell Lymphoma that have been treated with Temsirolimus as per clinical practice.
Exclusion Criteria:
Patients that do not have a minimum (pre-specified) of data in their clinical record.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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Patients that received treatment with Temsirolimus
Patients with Renal Cell Carcinoma or Mantle Cell Lymphoma that have been treated with Temsirolimus as per clinical practice.
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There is not any intervention in this study.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Progression-free Survival (PFS)
大体时间：From initiation of treatment up to disease progression (up to 80 months)
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Progression-free survival: interval between start of treatment to first day when progressive disease (PD) was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) for participants with RCC and Cheson criteria for participants with MCL, or death due to any cause.
RECIST criteria: at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum.
In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm).
Appearance of one or more new lesions also considered progression.
Cheson criteria: appearance of any new sites of lymphoma OR at least 50% increase in product of longest perpendicular dimensions of any previously identified lymph node mass (LNM) OR at least 50% increase in longest dimension of any previously identified LNM greater than 1 cm in longest transverse dimension OR at least 50% increase in size of any previously involved site of lymphoma.
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From initiation of treatment up to disease progression (up to 80 months)
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Percentage of Participants With Objective Response
大体时间：From initiation of treatment up to disease progression (up to 80 months)
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Objective response: percentage of participants who achieved complete remission (CR) or partial response (PR).
RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL.
RECIST criteria (CR: disappearance of all target lesions, any pathological lymph nodes(target or non-target) reduced in short axis to <10 mm, PR: at least 30% decrease in sum of diameters of target lesions).
Cheson criteria (CR: all lymph node masses regressed to normal size, each lymph node mass that was >1.5 cm in longest transverse dimension regressed to <=1.5 cm, lymph node mass that was 1.1-1.5 cm regressed to <=1 cm, complete disappearance of all radiographic evidence of disease, PR: at least 50% decrease in sum of products of the longest perpendicular dimensions of the previously identified dominant lymph node masses, no increase in size of other lymph nodes.)
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From initiation of treatment up to disease progression (up to 80 months)
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Duration of Response (DOR)
大体时间：From initiation of treatment up to disease progression (up to 80 months)
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Duration of response (DOR) was defined as the interval from the date the response was documented to the first date that progression of disease (PD) was observed in participants with PR or CR.
RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL.
PD, CR and PR are defined in primary outcome 1 and 2.
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From initiation of treatment up to disease progression (up to 80 months)
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Overall Survival (OS)
大体时间：From initiation of treatment untill death (up to 80 months)
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Overall survival (OS) was defined as the interval from the day of the start of the treatment to death, or censored to the last date when the participant was identified to be alive.
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From initiation of treatment untill death (up to 80 months)
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Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
大体时间：Baseline to the 28 calendar days after the last administration of study drug (upto 80 months)
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Treatment-emergent events were between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
AEs included both SAEs and non-serious adverse events (Non-SAEs).
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Baseline to the 28 calendar days after the last administration of study drug (upto 80 months)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年1月1日
初级完成 (实际的)
2015年4月1日
研究完成 (实际的)
2015年4月1日
研究注册日期
首次提交
2011年6月3日
首先提交符合 QC 标准的
2011年6月6日
首次发布 (估计)
2011年6月7日
研究记录更新
最后更新发布 (估计)
2016年4月27日
上次提交的符合 QC 标准的更新
2016年3月25日
最后验证
2016年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.