EUCTR2008-006209-17-SK进行中（未招募）1 期
A Phase 1/Randomized Phase 2 Study to Evaluate LY2603618 in Combination with Gemcitabine in Patients with Pancreatic Cancer - JMMC
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 149
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
- 性别
- All
入选标准
- •[1] Phase 1 portion: Have histological or cytological evidence of a
- •diagnosis of cancer that is advanced and/or metastatic disease; that is
- •refractory to standard therapy and/or therapies known to provide
- •clinical benefit or for which no standard therapy exists; and/or in
- •which gemcitabine therapy at the proposed doses and schedule would
- •be considered appropriate treatment for the metastatic disease.
- •[2] Phase 2 portion: Histological or cytological diagnosis of
- •adenocarcinoma of the pancreas that is locally advanced (Stage II, III)
- •or metastatic (Stage IV) and not amenable to resection with curative
- •[3] For Phase 2 only: Have measurable disease or non-measurable
- •disease, defined according to RECIST
- •[4] Males or females at least 18 years of age
- •[5] Have given written informed consent prior to any study-specific
- •procedures.
- •[6] Have adequate organ function(hematologic, hepatic, renal)
- •[7] Have a performance status of =2 on the ECOG scale
- •[8] For Phase 1: Patients enrolling in Phase 1 portion of study may have
- •prior chemotherapy, radiotherapy, cancer-related hormone therapy, or
- •other investigational therapy as treatment. There is no limit in the
- •number of previous lines of therapy.
- •For Phase 2: Patients may have received previous adjuvant treatment
- •with gemcitabine with or without radiotherapy for pancreas cancer.
- •[9] Are reliable and willing to make themselves available for the duration
- •of the study and are willing to follow study procedures.
- •[10] Males and females with reproductive potential must agree to use
- •medically approved contraceptive precautions during the trial until the
- •patient’s physicians deems it safe to become pregnant or father a child.
- •[11] Females with child bearing potential must have had a negative urine
- •pregnancy test =7 days prior to the first dose of study drug.
- •[13] Prior radiation therapy for treatment of cancer other than pancreatic is
- •allowed to <25% of the bone marrow, and patients must have recovered from the acute toxic effects of their treatment prior to study enrollment. Prior radiation to the whole pelvis is not allowed.
- •[14] Baseline ECG QTc interval corrected by Bazett’s method (should be <450 msec for males and <470 msec for females.
- •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 149
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •[15] Are currently enrolled in, or discontinued within the last 30 days from,
- •a clinical trial involving an off-label use of an investigational drug or
- •device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- •[16] Have serious preexisting medical conditions or serious concomitant
- •systemic disorders that would compromise the safety of the patient or
- •his/her ability to complete the study, at the discretion of the
- •investigator
- •[17] Have symptomatic central nervous system malignancy or metastasis
- •[18] Have current active infection that would, in the opinion of the
- •investigator, compromise the patient’s ability to tolerate therapy.
- •[19] Females who are pregnant or lactating.
- •[20] Have known positive test results in human immunodeficiency virus
- •(HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies
- •[21] Phase 2 only: Endocrine pancreatic tumors or ampullary cancer.
- •[22] Phase 1: Patients with acute or chronic leukemia or with any other
- •disease likely to have a significant bone marrow infiltration
- •[23] Have previously completed or withdrawn from this study or any other
- •study investigating LY2603618 or any other Chk-1 inhibitor.
- •[24] Have known allergy to gemcitabine or LY2603618 or any ingredient
- •of gemcitabine or LY2603618.
- •[25] Has an abnormal ECG result that would put the patient at unnecessary
- •risk in the opinion of the investigator.
- •[26] Have conduction abnormalities, ischemic changes such as prior Qwave
- •myocardial infarction and/or marked ischemic ST and T wave,
- •and arrhythmias such as persistent or paroxysmal ventricular or
- •supraventricular arrhythmias, including atrial fibrillation.
研究者
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