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Study to Evaluate Efficacy of CO-1.01 as Second Line Therapy for Gemcitabine-Refractory Stage IV Pancreatic Adenocarcinoma

2019年3月5日 更新者：Clovis Oncology, Inc.

A Phase II, Open-Label, Multicenter Study to Evaluate the Antitumor Efficacy of CO-1.01 for Infusion as Second-Line Therapy for Gemcitabine- Refractory Patients With Stage IV Pancreatic Adenocarcinoma and No Tumor hENT1 Expression

The purpose of this study is to determine whether CO-1.01 is safe and effective for treating metastatic pancreatic cancer that did not respond to gemcitabine.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Pancreatic tumors with low hENT1 expression may show less benefit from gemcitabine compared with those with higher expression of this nucleoside transporter. Nonclinical studies indicate that CO-1.01, a gemcitabine derivative, is effective independent of such transporters. Thus patients with low or no meaningful expression of hENT1 who failed to respond to gemcitabine might derive benefit from CO1.01 before needing alternative (combination) chemotherapy. Furthermore, the PK profiles of CO-1.01 and gemcitabine are dissimilar and this may confer additional clinical benefit on CO1.01.

研究类型

介入性

注册 (实际的)

19

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

  • 美国
    • Arizona
      • Tucson、Arizona、美国、85724
        • Arizona Cancer Center at University of Arizona
    • Colorado
      • Denver、Colorado、美国、80218
        • Rocky Mountain Cancer Center
    • Florida
      • Boynton Beach、Florida、美国、33425
        • Palm Beach Institute / Collaborative Research Group
      • Miami、Florida、美国、33136
        • University of Miami
    • Georgia
      • Atlanta、Georgia、美国、30309
        • Piedmont Healthcare Research Institute (PHRI)
    • Kentucky
      • Louisville、Kentucky、美国、40202
        • Norton Cancer Institute Research Program
    • Maryland
      • Baltimore、Maryland、美国、21231
        • Johns Hopkins Oncology Center
    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • Massachusetts General Hospital (MGH)
    • New York
      • New York、New York、美国、10021
        • Memorial Sloan-Kettering Cancer Center
      • New York、New York、美国、10032
        • Columbia University Medical Center, Milstein Hospital
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73104
        • University of Oklahoma Health Sciences Center
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15232-1305
        • University of Pittsburgh Cancer Institute
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53226
        • Medical College of Wisconsin

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:

  1. Gemcitabine-refractory metastatic ductal adenocarcinoma of the pancreas

    • At least 1 measurable lesion according to RECIST 1.1 criteria
    • Computerized tomography (CT) scan ≤ 28 days prior to CO-1.01
    • First-line treatment included at least 3 doses of gemcitabine (as monotherapy or combination therapy) with the last dose administered at least 2 weeks prior to CO 1.01
    • Radiological best response of disease progression after 1st-line treatment (no radiological stable disease or better allowed at any time)
    • Patients who experienced progressive disease during (neo)-adjuvant gemcitabine-based therapy are also eligible
    • Patients who have completed previous adjuvant therapy without progression, then subsequently have a radiological best response of disease progression on 1st line gemcitabine for metastatic disease are eligible
  2. No hENT1 expression in primary or metastatic tumor sample, confirmed with IHC by a core pathology laboratory prior to study entry also eligible
  3. Performance Status (ECOG) 0 or 1
  4. Age ≥18 years
  5. Palliative radiotherapy (if administered) ≥2 weeks prior to CO-1.01
  6. Adequate hematological and biological function, with no residual gemcitabine-related toxicity
  7. Written consent on an Institutional Review Board (IRB)-approved IC Form prior to any study-specific evaluation

Exclusion Criteria:

  1. Patients who have had stable disease, partial response or complete response to first line gemcitabine-based therapy
  2. First-line chemotherapy regimen that does not contain gemcitabine
  3. First-line treatment discontinued due to intolerable gemcitabine-induced toxicity
  4. Second or subsequent line therapy for advanced disease. Prior exposure to CO-1.01 or prior randomization in a protocol studying CO-1.01 (e.g.,Protocol CO-101-001)
  5. Tumor that cannot be evaluated for hENT1 expression or that has hENT1 staining in >50% of cells
  6. Symptomatic brain metastases
  7. Concomitant treatment with prohibited medications (e.g., concurrent anticancer therapy including other chemotherapy, radiation, hormonal treatment [except corticosteroids and megestrol acetate], or immunotherapy) ≤14 days prior to CO-1.01
  8. Exploratory laparotomy, palliative (e.g., bypass) surgery, or other procedures are not allowed <14 days prior to CO-1.01 administration; stenting procedures are permissible at any time prior to dosing; in all cases, the patient must be sufficiently recovered and stable
  9. History of allergy to gemcitabine or eggs
  10. Females who are pregnant or breastfeeding
  11. Refusal to use adequate contraception for fertile patients (females and males during the study and for 6 months after the last dose of CO-1.01)
  12. Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, psychiatric disturbance, uncontrolled intercurrent illness including active infection, arterial thrombosis, or symptomatic pulmonary embolism)
  13. Any other reason for which 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：非随机化
  • 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
实验性的：CO-1.01
药品：CO-1.01

1250 mg/m2/day administered on Days 1, 8, and 15 in 4-week treatment cycles.

Patients who have SD or better at the Week 8 assessment and who adequately tolerated the first 2 cycles of treatment may continue CO-1.01 at the same or an increased dose (1400 mg/m2) for Cycle 3 and subsequent cycles.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Disease Control Rate (CR, PR, or SD) using RECIST 1.1
大体时间：Every 8 weeks until disease progression
Every 8 weeks until disease progression

次要结果测量

结果测量
大体时间
Overall Response Rate (ORR)
大体时间：Every 8 weeks
Every 8 weeks
CA 19-9 response rate
大体时间：Every 4 weeks
Every 4 weeks
Progression-free survival (PFS)
大体时间：Every 8 weeks
Every 8 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
大体时间：Every week
Every week
Overall survival (OS)
大体时间：3, 6, 9, and 12 months
3, 6, 9, and 12 months
Median progression-free survival
大体时间：3, 6, 9, and 12 months
3, 6, 9, and 12 months
Median overall survival
大体时间：3, 6, 9, and 12 months
3, 6, 9, and 12 months
Duration of response
大体时间：Every 8 weeks
Every 8 weeks

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.

调查人员

  • 首席研究员：Eileen O'Reilly, M.D.、Memorial Sloan Kettering Cancer Center

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4月1日

初级完成 (实际的)

2013年3月1日

研究完成 (实际的)

2013年3月1日

研究注册日期

首次提交

2010年10月26日

首先提交符合 QC 标准的

2010年11月1日

首次发布 (估计)

2010年11月3日

研究记录更新

最后更新发布 (实际的)

2019年3月11日

上次提交的符合 QC 标准的更新

2019年3月5日

最后验证

2019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-101-003

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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