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A Study Comparing CO-1.01 With Gemcitabine as First Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma (LEAP)

2014年3月12日 更新者：Clovis Oncology, Inc.

A Phase II Randomized, Open-Label, Multicenter Study Comparing CO-1.01 With Gemcitabine as First-Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma

The purpose of this study is to determine whether CO-1.01 is safe and effective in the treatment of patients with metastatic pancreatic cancer and low hENT1 expression compared with gemcitabine.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Pancreatic cancer is a very serious form of cancer. The majority of patients present with unresectable disease, and the condition is often not diagnosed until the cancer is relatively advanced. The standard first-line treatment for patients with unresectable pancreatic cancer is gemcitabine monotherapy. Unfortunately many of these patients fail to derive benefit from this treatment. No clinical or molecular marker has been established to predict benefit from gemcitabine therapy, so patients are treated empirically until evidence of disease progression or worsening performance status.

The potential for human equilibrative nucleoside transporter-1 (hENT1) expression to predict survival in gemcitabine-treated patients has been studied, and data suggest that patients with low levels of tumor cell hENT1 expression derive less benefit from gemcitabine treatment than patients with high levels of tumor cell hENT1 expression. These data support the hypothesis to be tested in this study that patients with pancreatic tumors expressing low levels of hENT1 will derive minimal benefit from gemcitabine, but will receive benefit from CO-1.01 (gemcitabine elaidate) which enters tumor cells in a hENT1-independent fashion.

研究类型

介入性

注册 (实际的)

367

阶段

  • 阶段2

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

  • 乌克兰
      • Dnipropetrovsk、乌克兰、49102
        • Dnipropetrovsk City Multispecialty Clinical Hospital #4, Department of Chemotherapy, Dnipropetrovsk State Medical Academy, Department of Oncology and Medical Radiology
      • Donetsk、乌克兰、83092
        • Public Clinical Treatment and Prophylaxis Institution "Donetsk Regional Antitumor Center", Oncosurgery Department #6
      • Kharkiv、乌克兰、61070
        • "Public Healthcare Institution ""Kharkiv Regional Clinical Oncology Center"", Abdominal Department
      • Kiev、乌克兰、03022
        • National Cancer Institute, Department of Tumors of Abdominal Cavity and Retroperitoneum
      • Lviv、乌克兰、79031
        • State Regional Diagnostics and Treatment Oncology Center, Chemotherapy Department
      • Mykolayiv、乌克兰、54044
        • Mykolayiv Regional Oncology Center, Surgery Department #1
      • Uzhorod、乌克兰、88014
        • Zakarpatya Regional Clinical Oncology Center, Chemotherapy Department
      • Zaporizhya、乌克兰、69032
        • Clinical Facility: Public Institution "Zaporizhya City Clinical Hospital #3", Regional Center of Hepatic, Biliary Tract and Pancreatic Surgery, Surgery Department #1
  • 俄罗斯联邦
      • Ekaterinburg、俄罗斯联邦、620036
        • Sverdlovsk Regional Oncology Center
      • Irkutsk、俄罗斯联邦、664035
        • Regional Oncology Center
      • Krasnodar、俄罗斯联邦、350040
        • Clinical Oncology Center #1
      • Kursk、俄罗斯联邦、305035
        • Kursk Regional Oncology Center
      • Moscow、俄罗斯联邦、115478
        • Blokhin Cancer Research Center
      • Novosibirsk、俄罗斯联邦、630047
        • Novosibirsk, City Clinical Hospital #1
      • St. Petersburg、俄罗斯联邦、194291
        • Leningrad Regional Clinical Hospital
      • St. Petersburg、俄罗斯联邦、195067
        • Mechnikov St. Petersburg State Medical Academy
      • St. Petersburg、俄罗斯联邦、197785
        • St. Petersburg City Oncology Center
      • Tambov、俄罗斯联邦、392013
        • Tambov Regional Oncology Center
      • Tula、俄罗斯联邦、300053
        • Tula Regional Oncology Center
      • Yaroslavl、俄罗斯联邦、150040
        • Regional Clinical Oncology Hospital
    • Republic of Udmurtia
      • Izhevsk、Republic of Udmurtia、俄罗斯联邦、426067
        • Republic Clinical Oncology Center
  • 加拿大
    • Alberta
      • Edmonton、Alberta、加拿大、T6G 1Z2
        • Cross Cancer Institute
  • 巴西
      • Rio de Janeiro、巴西、20231
        • Instituto Nacional do Câncer
    • Distrito Federal
      • Brasilia、Distrito Federal、巴西、70840
        • Hospital Universitario
    • Minas Gerais
      • Belo Horizonte、Minas Gerais、巴西、60430-230
        • Santa Casa de Misericordia de Belo Horizonte
    • Rio Grande Do Sul
      • Porto Alegre、Rio Grande Do Sul、巴西、90610-000
        • Hospital Sao Lucas - PUCRS
    • Rio Grande do Sul
      • Porto Alegre、Rio Grande do Sul、巴西、90020
        • Irmandade da Santa
    • Santa Catarina
      • Florianópolis、Santa Catarina、巴西、88034-000
        • CEPON-Centro de Pesquisas Oncológicas
    • Sao Paulo
      • Barretos、Sao Paulo、巴西、14784-400
        • Hospital do Cancer de Barretos
      • Jau、Sao Paulo、巴西、17210
        • Fundacao Hospital
      • Santo Andre、Sao Paulo、巴西、09060-650
        • Faculdade de Medicina do ABC
  • 德国
      • Berlin、德国、13353
        • Charité Universitätsmedizin Berlin
      • Dresden、德国、01307
        • Universitatsklinikum Carl Gustav Carus
      • Magdeburg、德国、39120
        • Klinik der Otto-Von-Guericke-Universität Magdeburg
      • Ulm、德国、89081
        • Medizinische Universitätsklinik Ulm, Abt. Innere Medizin I
    • Bayern
      • München、Bayern、德国、81377
        • Ludwig-Maximilians-Universität, Medizinische Klinik und Poliklinikversität München
    • Mecklenburg-Vorpommern
      • Greifswald、Mecklenburg-Vorpommern、德国、17475
        • Klinikum der Ernst-Moritz-Arndt-Universität
    • Nordrhein-Westfalen
      • Bochum、Nordrhein-Westfalen、德国、44892
        • Knappschaftskrankenhaus Bochum-Langendreer
    • Thueringen
      • Jena、Thueringen、德国、07740
        • Universitatsklinikum Jena
  • 意大利
      • Milano、意大利、20132
        • Fondazione San Raffaele del Monte Tabor
      • Padova、意大利、35128
        • Instituto Oncologico Veneto, Oncologia Medica 1
      • Torrette di Ancona、意大利、60020
        • Ospedali Riuniti di Ancona
      • Verona、意大利、37134
        • Centro Ricerche Cliniche Di Verona
    • Emilia-Romagna
      • Bologna、Emilia-Romagna、意大利、40138
        • Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
  • 挪威
      • Kristiansand、挪威、4604
        • Sørlandet Sykehus HF
      • Oslo、挪威、0407
        • Oslo universitetssykehus, Ullevål
  • 比利时
      • Brussels、比利时、1200
        • Cliniques Universitaires Saint Luc
      • Haine-Saint-Paul、比利时、7100
        • Centre Hospitalier de Jolimont-Lobbes
    • Antwerpen
      • Edegem、Antwerpen、比利时、2650
        • Universitair Ziekenhuis Antwerpen
  • 法国
      • Bayonne Cedex、法国、64109
        • Centre Hospitalier de la Côte Basque
      • Bordeaux、法国、33000
        • Hôpital Saint André, Service d'Oncologie Médicale
      • Limoges Cedex、法国、87039
        • Clinique Francois Chenieux
      • Montpellier、法国、34298
        • Centre Regional de Lutte contre le Cancer Val d'Aurelle
      • Montpellier Cedex 5、法国、34295
        • Centre Hospitalier Régional Universitaire Hôpital Saint Eloi
      • Saint Herblain cedex、法国、44805
        • Centre Rene Gauducheau
      • Villejuif Cedex、法国、94805
        • Institut Gustave-Roussy - Centre de Lutte Contre le Cancer
  • 澳大利亚
    • New South Wales
      • New Lambton Heights、New South Wales、澳大利亚、2305
        • Newcastle Private Hospital
      • Port Macquarie、New South Wales、澳大利亚、2444
        • Port Macquarie Base Hospital
      • Wollongong、New South Wales、澳大利亚、2500
        • Southern Medical Day Oncology Care Centre
    • South Australia
      • Bedford Park、South Australia、澳大利亚、5042
        • Flinders Medical Centre
    • Victoria
      • Fitzroy、Victoria、澳大利亚、3065
        • Saint Vincent's Hospital
      • Wodonga、Victoria、澳大利亚、3690
        • Border Medical Oncology, Murray Valley Private Hospital
  • 瑞典
      • Jonkoping、瑞典、551 85
        • Länssjukhuset Ryhov
      • Linköping、瑞典、581 85
        • Linköping University Hospital
      • Växjö、瑞典、351 85
        • Växjö Centrallasarettet
  • 美国
    • Arizona
      • Glendale、Arizona、美国、85306
        • Arizona Center for Hematology Oncology
    • California
      • Corona、California、美国、92879
        • Wilshire Oncology Medical Group, Inc.
      • Los Angeles、California、美国、90033
        • White Memorial Medical Center
      • Los Angeles、California、美国、90036
        • Cancer Care Institute
      • Newport Beach、California、美国、92660
        • Newport Cancer Care Medical
      • Oakland、California、美国、94609
        • Hematology Oncology Associates
      • San Diego、California、美国、92123
        • Sharp Clinical Oncology Research
    • Colorado
      • Denver、Colorado、美国、80218
        • Rocky Mountain Cancer Centers
    • Connecticut
      • Hartford、Connecticut、美国、06102
        • Hartford Hospital Clinical Research
      • Trumbull、Connecticut、美国、06611
        • Oncology Associates of Bridgeport
    • Maryland
      • Annapolis、Maryland、美国、21401
        • Annapolis Oncology Center
    • Minnesota
      • Minneapolis、Minnesota、美国、55407
        • Virginia Piper Cancer Institute
    • New Jersey
      • New Brunswick、New Jersey、美国、08901
        • The Cancer Institute of New Jersey
    • New Mexico
      • Albuquerque、New Mexico、美国、87109
        • New Mexico Cancer Care Alliance
    • New York
      • Lake Success、New York、美国、11042
        • Arena Oncology Associates, PC
    • Oregon
      • Bend、Oregon、美国、97701
        • Bend Memorial Clinic
    • South Carolina
      • Greenville、South Carolina、美国、29605
        • Cancer Center Of The Carolinas
    • Texas
      • Corpus Christi、Texas、美国、78412
        • Cancer Specialists of South Texas, P.A.
      • Harlingen、Texas、美国、78550
        • Valley Cancer Associates
      • San Antonio、Texas、美国、78229
        • South Texas Oncology and Hematology, PA
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53226
        • Medical College of Wisconsin
  • 英国
    • England
      • London、England、英国、W12 0HS
        • Hammersmith Hospital
      • Manchester、England、英国、M20 4BX
        • Christie Hospital
    • Scotland
      • Glasgow、Scotland、英国、G12 0YN
        • Beatson West of Scotland Cancer Centre, Cancer Research UK Clinical Trials Unit (CTU)
  • 荷兰
    • Noord-Holland
      • Amsterdam、Noord-Holland、荷兰、1081 HV
        • Vrije Universiteit Medisch Centrum
  • 阿根廷
      • Córdoba、阿根廷、X5004FHP
        • Clínica Universitaria Reina Fabiola
      • Santa Fe、阿根廷、S3000FFU
        • ISIS Centro especializado
    • Bahia Blanca
      • Buenos Aires、Bahia Blanca、阿根廷、B8000FJI
        • Policlínica Privada Instituto de Medicina Nuclear
    • Buenos Aires
      • Cuidad Autónoma de Buenos Aires、Buenos Aires、阿根廷、C1426ANZ
        • Instituto Especializado Alexander Fleming
      • Loma Hermosa、Buenos Aires、阿根廷、B1657BHD
        • Hospital de Gastroenterología

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:

  • Metastatic pancreatic ductal adenocarcinoma (i.e., Stage 4).
  • Histological/cytological confirmation of metastatic tissue (not primary tumor) by a central pathology laboratory (H&E stain) to ensure sufficient material is available for later hENT1 analysis.
  • Adjuvant chemotherapy/radiotherapy ≥ 6 months prior to randomization.
  • Palliative radiotherapy (if administered) ≥ 1 month prior to randomization.
  • CT scan ≤30 days prior to randomization
  • Performance Status (ECOG) 0 or 1.
  • Estimated life expectancy ≥ 12 weeks.
  • Age ≥ 18 years.
  • Adequate hematological and biological function.
  • Written consent on an Institutional Review Board/Institutional Ethics Committee-approved Informed Consent Form prior to any study-specific evaluation.

Exclusion Criteria:

  • Prior palliative chemotherapy for pancreatic cancer.
  • Radical pancreatic resections (e.g., Whipple procedure) are not allowed < 6 months prior to randomization. Exploratory laparotomy, palliative (e.g., bypass) surgery, or other procedures (e.g., stents) are not allowed < 14 days prior to randomization. In both cases the patient must be sufficiently recovered and stable.
  • Symptomatic brain metastases.
  • Participation in other investigational drug clinical studies ≤ 30 days prior to randomization.
  • Concomitant treatment with prohibited medications.
  • History of allergy to gemcitabine or eggs.
  • Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, uncontrolled intercurrent illness including active infection, arterial thrombosis, symptomatic pulmonary embolism).
  • Any disorder that would hamper protocol compliance.
  • Prior nonpancreatic malignancy treated with chemotherapy. Prior malignancies treated with surgery or radiotherapy alone must be in remission ≥ 3 years. The following prior malignancies are allowable irrespective of when they occurred: in situ carcinoma of the cervix, in situ ductal breast cancer, low-grade local bladder cancer, and nonmelanotic skin cancer.
  • Females who are pregnant or breastfeeding.
  • Refusal to use adequate contraception for fertile patients (females and males during the study and for 6 months after the last study treatment). Adequate forms of contraception are double-barrier methods (condoms or diaphragm with spermicidal jelly or foam); oral, depot, or injectable contraceptives; intrauterine devices; tubal ligation.
  • Any other reason the investigator considers the patient should not participate in the study.

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：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：吉西他滨
药品：Gemcitabine
1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
实验性的：CO-1.01
药品：CO-1.01
1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Overall Survival in Patients With Low High Human Equilibrative Nucleoside Transporter 1 (hENT1) Expression
大体时间：Monthly follow up after treatment discontinuation until death, up to 1.5 years.
Monthly follow up after treatment discontinuation until death, up to 1.5 years.

次要结果测量

结果测量
大体时间
Overall Survival in All Patients and Patients With hENT1 Expression
大体时间：Monthly follow up after treatment discontinuation until death, up to 1.5 years
Monthly follow up after treatment discontinuation until death, up to 1.5 years
ORR, Duration of Response, and Progression Free Survival (PFS) in Patients With Measurable/Evaluable Disease, Using RECIST 1.1, up to 1.5 Years
大体时间：Every 8 weeks
Every 8 weeks
Cancer Antigen (CA)19-9 Response Rates
大体时间：Every 4 weeks, up to 1.5 years
Every 4 weeks, up to 1.5 years
Drug Tolerability and Toxicity
大体时间：Every week, up to 1.5 years
Every week, up to 1.5 years
Change From Baseline in Pain Severity
大体时间：Every 4 weeks, up to 1.5 years
Every 4 weeks, up to 1.5 years
Change From Baseline in Health Status
大体时间：Every 4 weeks, up to 1.5 years
Every 4 weeks, up to 1.5 years
Pharmacokinetic (PK) Profile of CO-1.01 Based on Sparse Sampling
大体时间：30 days after first dose
30 days after first dose

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

Clovis Oncology, Inc.

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

2010年5月1日

初级完成 (实际的)

2012年11月1日

研究完成 (实际的)

2013年6月1日

研究注册日期

首次提交

2010年5月12日

首先提交符合 QC 标准的

2010年5月14日

首次发布 (估计)

2010年5月17日

研究记录更新

最后更新发布 (估计)

2014年4月17日

上次提交的符合 QC 标准的更新

2014年3月12日

最后验证

2014年3月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CO-101-001

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.

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