Panitumumab Regimen Evaluation in Colorectal Cancer to Estimate Primary Response to Treatment (PRECEPT)
2016年1月15日 更新者：Amgen
Multi Center, Open Label, Single Arm Trial Evaluating Panitumumab in Combination With FOLFIRI Therapy Following First Line FOLFOX and Bevacizumab Treatment of Metastatic Colorectal Cancer
The primary objective is to estimate the effect of the human homolog of the Kirsten rat sarcoma-2 virus oncogene (KRAS) mutation status (wild type versus mutant) from tumor tissue on efficacy endpoints in patients with metastatic colorectal cancer (mCRC) receiving second-line chemotherapy with panitumumab after failing first-line treatment.
研究概览
研究类型
介入性
注册 (实际的)
116
阶段
- 阶段2
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
描述
Inclusion Criteria:
- Diagnosis of metastatic adenocarcinoma of the colon or rectum
- Available paraffin-embedded tumor tissue
- Failure of first line treatment containing fluoropyrimidine and oxaliplatin based chemotherapy with bevacizumab for mCRC
- Measurable disease
- Adequate hematologic, renal, hepatic and metabolic function
Exclusion Criteria:
- Radiotherapy ≤ 2 weeks prior to Day 1 of Cycle 1
- Unresolved toxicity(ies) from prior anti cancer therapy that, in the opinion of the investigator, precludes the subject from study enrollment
- Prior irinotecan therapy, anti epidermal growth factor receptor (EGFr) therapy, or vaccine for the treatment of mCRC
- CYP3A4 enzyme inducers, inhibitors, and substrates (eg, phenytoin, phenobarbital, carbamazepine, ketoconazole, rifampin, rifabutin, and St. John's Wort) ≤ 2 weeks prior to Day 1 of Cycle 1
- Infection requiring systemic anti infectives completed ≤ 2 weeks prior to Day 1 of Cycle 1
- Clinically significant cardiovascular disease
- History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis)
- Pulmonary embolism, deep vein thrombosis, or other significant thromboembolic event ≤ 8 weeks prior to Day 1 of Cycle 1
- Any significant bleeding ≤ 6 weeks prior to Day 1 of Cycle 1, per the investigator's judgement
- Gastroduodenal ulcer(s) determined by endoscopy to be active or uncontrolled gastrointestinal ulcer ≤ 4 weeks prior to Day1 of Cycle 1
- Any co-morbid disease or condition that could increase the risk of toxicity (eg, dihydropyrimidine deficiency, significant ascites, or pleural effusion)
- Major surgery (requiring general anesthesia), open biopsy, or significant traumatic injury ≤ 4 weeks prior to Day1 of Cycle 1. Subjects must have recovered from surgery and have no significant complications
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
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Panitumumab plus FOLFIRI
Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
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通过静脉输液给药
其他名称：
化疗包括伊立替康和输注 5-氟尿嘧啶和亚叶酸。
FOLFIRI 的推荐剂量方案和给药基于当地的护理标准、每种产品的包装说明书和机构指南。
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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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Objective Response Rate at Weeks 17 and 25
大体时间：Week 17 and Week 25
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Objective response rate is defined as the percentage of participants with a best response of complete response or partial response.
Disease assessments were based on investigator review of scans using modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
A complete or partial response was confirmed no less than 4 weeks after the criteria for response were first met.
Participants with no radiographic tumor assessment(s) at Week 17 or 25 were considered non-responders.
Complete Response (CR): disappearance of all target and non-target lesions and no new lesions.
Partial Response (PR): At least a 30% decrease in the size of target lesions with no progression of non-target lesions (defined as a ≥ 25% increase in lesion size) and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or progressive disease (PD) and no new lesions.
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Week 17 and Week 25
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Best Response During Second-Line Treatment
大体时间：Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.
|
Objective response rate is defined as the percentage of participants with a best response of complete response or partial response based on investigator review of scans using modified RECIST criteria. A complete or partial response was confirmed no less than 4 weeks after the criteria for response were first met. Participants with no post-baseline radiographic tumor assessment(s) were considered non-responders. CR: disappearance of all target and non-target lesions and no new lesions. PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions (defined as a ≥ 25% increase in lesion size) and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or PD and no new lesions. |
Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.
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Progression-free Survival Rate at Weeks 17 and 25
大体时间：Week 17 and Week 25
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The progression-free survival rate is defined as the Kaplan-Meier (KM) estimator of progression-free survival at Week 17 and Week 25 reported as the probability of being event (disease progression or death)-free. Tumor assessments were evaluated by the investigator according to modified RECIST criteria. PD: At least a 20% increase in the size of target lesions since the treatment started or at least a 25% increase in the size of non-target lesions and the lesion(s) measure ≥ 10 mm, or the appearance of any new lesions. Participants who withdraw from the study prior to completion of Week 17 or 25 radiographic tumor assessments were censored at the last evaluable tumor assessment. |
Week 17 and Week 25
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Progression-free Survival Time
大体时间：From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.
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Progression-free survival time was defined as the time from Study Day 1 to the date of disease progression (based on investigator assessment) or the date of death due to any cause.
Participants who terminated from the study early (eg, prior to disease progression due to fully withdrawn informed consent) were censored at their last tumor assessment.
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From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.
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Disease Control Rate at Weeks 17 and 25
大体时间：Week 17 and Week 25
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The percentage of participants whose best response was either a complete or partial response or stable disease, based on modified RECIST criteria as assessed by the investigator.
Stable diease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD of target lesions and no progression of existing non-target lesions and no new lesions, or, the persistence of 1 or more non-target lesions not qualifying for either CR or PD if no target lesions were identified at Baseline.
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Week 17 and Week 25
|
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Duration of Response
大体时间：Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.
|
Duration of response is defined as the time from the date of first response to the date of first progression of disease during second-line treatment (as evaluated by the investigator) or death (if the death was due to disease progression but not detected earlier) in the subset of participants who responded (CR or PR, as evaluated by the investigator).
Duration of response was analyzed using Kaplan-Meier methods; participants who responded but did not progress while on study were censored at the date of last tumor assessment.
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Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.
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Overall Survival
大体时间：From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.
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Overall survival is defined as as the number of days from Study Day 1 to the date of death due to any cause.
Overall survival was analyzed using the Kaplan-Meier method; participants who were lost to follow-up or who had not died at the end of the study (52 weeks after the last participant was enrolled) were censored at the date of last contact.
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From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.
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Time to Treatment Failure
大体时间：Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.
|
Time to failure of second-line treatment is defined as the time from study Day 1 to the date of the earliest of the following events: end of second-line therapy due to any reason except for complete response and curative surgery; progressive disease; or death due to any cause.
Time to treatment failure was analyzed using Kaplan-Meier methods; participants who did not discontinue second-line treatment or discontinue due to complete response or curative surgery, who were still alive, and who did not have disease progression were censored at the date of the last contact.
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Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.
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Time to Progression
大体时间：From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.
|
Time to progression is defined as the time from study Day 1 to the date of observed disease progression.
Time to progression was analyzed using Kaplan-Meier methods; participants who did not have disease progression were censored at the date of last evaluable tumor assessment.
|
From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.
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Time to Response
大体时间：Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.
|
Time to response of second-line treatment is defined as the time from study Day 1 to the date of first documentation of CR or PR, calculated for those participants with an objective tumor response of CR or PR.
|
Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants With Adverse Events
大体时间：From the first dose date to 30 days after the last dose date. The median time frame is 4.5 months.
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The severity of adverse events (AEs) was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, except for panitumumab related skin toxicities, where Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE.
The relationship of each adverse event to the panitumumab and/or FOLFIRI regimen was assessed by the investigator.
A serious adverse event was defined as an adverse event that • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard.
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From the first dose date to 30 days after the last dose date. The median time frame is 4.5 months.
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Number of Participants With Grade 4 Laboratory Toxicities
大体时间：From the first dose date to 30 days after the last dose date. The median time frame is 4.5 months.
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Laboratory toxicities were graded according to CTCAE version 3.
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From the first dose date to 30 days after the last dose date. The median time frame is 4.5 months.
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Number of Participants Who Developed Antibodies to Panitumumab
大体时间：Prior to first dose and 28 days after the last dose of second-line treatment
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The immunogenicity of panitumumab was evaluated using 2 different screening immunoassays for the detection of anti-panitumumab antibodies: an acid dissociation bridging enzyme-linked immunosorbent assay (ELISA; detecting high-affinity antibodies) and a Biacore® biosensor immunoassay (detecting both high and low-affinity antibodies).
When either of the 2 screening assays yielded a positive result, that particular sample was subjected to an in vitro bioassay for the detection of neutralizing antibodies.
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Prior to first dose and 28 days after the last dose of second-line treatment
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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。
一般刊物
- Weeraratne D, Chen A, Pennucci JJ, Wu CY, Zhang K, Wright J, Perez-Ruixo JJ, Yang BB, Kaliyaperumal A, Gupta S, Swanson SJ, Chirmule N, Starcevic M. Immunogenicity of panitumumab in combination chemotherapy clinical trials. BMC Clin Pharmacol. 2011 Nov 9;11:17. doi: 10.1186/1472-6904-11-17.
- Cohn AL, Shumaker GC, Khandelwal P, Smith DA, Neubauer MA, Mehta N, Richards D, Watkins DL, Zhang K, Yassine MR. An open-label, single-arm, phase 2 trial of panitumumab plus FOLFIRI as second-line therapy in patients with metastatic colorectal cancer. Clin Colorectal Cancer. 2011 Sep;10(3):171-7. doi: 10.1016/j.clcc.2011.03.022. Epub 2011 Apr 28.
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
2006年11月1日
初级完成 (实际的)
2009年1月1日
研究完成 (实际的)
2010年10月1日
研究注册日期
首次提交
2006年12月12日
首先提交符合 QC 标准的
2006年12月13日
首次发布 (估计)
2006年12月14日
研究记录更新
最后更新发布 (估计)
2016年2月15日
上次提交的符合 QC 标准的更新
2016年1月15日
最后验证
2016年1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.