EUCTR2016-002218-36-ES进行中（未招募）1 期
An Adaptive, Open-Label, Randomized Phase 2 Study of Abemaciclib as a Monotherapy and in Combination with Other Agents Versus Choice of Standard of Care (Gemcitabine or Capecitabine) in Patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma
illy S.A.0 个研究点目标入组 256 人开始时间: 2016年11月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 256
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •[1] have cytologically or histologically confirmed diagnosis of ductal
- •adenocarcinoma of the pancreas.
- •[2] have metastatic disease with documented disease progression following
- •previous treatment with at least one, but no more than 2 prior therapies, with
- •one of the prior therapies having been either gemcitabine-based or
- •fluoropyrimidine-based therapy. Neoadjuvant and/or adjuvant therapies for
- •localized resectable or unresectable PDAC each count as a line of therapy if
- •multiagent chemotherapy regimens were administered (and neoadjuvant
- •regimen was different than adjuvant regimen) and if the patient progressed
- •with metastatic disease while taking or within 6 months of completion of
- •(neo)adjuvant therapy.
- •[3] have the presence of measurable disease as defined by Response Evaluation
- •Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
- •[4] have a performance status (PS) of 0 to 1 on the ECOG scale
- •[5] is a patient for whom treatment with monotherapy chemotherapy such as
- •gemcitabine or capecitabine is a reasonable choice.
- •have discontinued all previous treatments for cancer (including cytotoxic
- •chemotherapy, molecularly targeted therapy, radiotherapy, immunotherapy,
- •and investigational therapy) for at least 14 days prior to receiving the initial
- •dose of study treatment, and recovered from the acute effects of therapy
- •(treatment-related toxicity resolved to baseline) except for residual alopecia or
- •peripheral neuropathy.
- •[7} have adequate organ functions
- •[8] are at least 18 years old at the time of screening or of an age acceptable
- •according to local regulations, whichever is older.
- •[9] men must be sterile or agree to use an effective method of contraception or a
- •highly effective method of contraception during the study and for at least
- •6 months following the last dose of study drug.
- •[10] women of child-bearing potential must:
- •a. have a negative serum pregnancy test within 7 days prior to study
- •treatment initiation, and
- •b. agree to use a highly effective method of contraception during the study
- •and for at least 6 months following the last dose of study drug.
- •[11] have given written informed consent prior to any study-specific procedures.
- •[12] are able to swallow capsules and tablets.
- •[13] are reliable and willing to make themselves available for the duration of the
- •study and are willing to follow study procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 156
排除标准
- •Patients will be excluded from the study if they meet any of the following criteria:
- •[14] have a serious concomitant systemic disorder or preexisting condition (for
- •example, active infection including human immunodeficiency virus, history of
- •major surgical resection involving the stomach or small bowel, or preexisting
- •Crohn’s disease or ulcerative colitis) that, in the opinion of the investigator,
- •would compromise the patient’s safety or ability to adhere to the protocol.
- •[15] have severe cardiac disease:
- •? Myocardial infarction within 6 months prior to study screening, unstable angina
- •pectoris, New York Heart Association Class III/IV congestive heart failure, or
- •uncontrolled hypertension.
- •? Documented major electrocardiogram (ECG) abnormalities, at the investigator’s
- •discretion (for example, symptomatic or sustained atrial or ventricular
- •arrhythmias, second- or third-degree atrioventricular block, bundle branch blocks,
- •ventricular hypertrophy, or recent myocardial infarction), not responding to
- •medical treatments or not clinically stable for at least 6 months prior to study
- •? Major cardiac abnormalities documented by echocardiography (ECHO) with
- •Doppler that are not clinically stable for at least 6 months prior to study screening
- •(for example, severe heart valve function defect and/or left ventricular ejection
- •fraction [LVEF] <50%, evaluation based on the institutional lower limit of
- •normal). For additional details, refer to Echocardiography Protocol (Appendix 6).
- •[16] Predisposing conditions that are consistent with development of aneurysms of
- •the ascending aorta or aortic stress (for example, family history of aneurysms,
- •Marfan-Syndrome, bicuspid aortic valve, or evidence of damage to the large
- •vessels of the heart documented by Computed Tomography [CT] scan or
- •magnetic resonance imaging [MRI] with contrast).
- •[17] have insulin-dependent diabetes mellitus. Patients with type 2 diabetes
- •mellitus are eligible if adequate control of blood glucose level is obtained by
- •oral anti-diabetics as documented by hemoglobin A1c (HbA1c) <7%.
- •[18] have symptomatic central nervous system metastasis. Screening of asymptomatic patients is not required for enrollment.Screening is not required for enrollment.
- •[19] have a history of any other cancer (except nonmelanoma skin cancer or
- •carcinoma in-situ of the cervix), unless in complete remission with no therapy
- •for a minimum of 2 years.
- •[20] have had major surgery within 7 days prior to initiation of study drug to allow for
- •postoperative healing of the surgical wound and site(s).
- •[21] are currently enrolled in a clinical trial involving an investigational product or
- •any other type of medical research judged not to be scientifically or medically
- •compatible with this study. If a patient is currently enrolled in a clinical trial
- •involving nonapproved use of a device, then agreement w
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