EUCTR2008-006209-17-IT进行中（未招募）不适用
A Phase 1/Randomized Phase 2 Study to Evaluate LY2603618 inCombination with Gemcitabine in Patients with Pancreatic Cancer - JMMC
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ELI LILLY
- 入组人数
- 99
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
- •[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 intent. [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: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
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 XML File Identifier: RbejZKBN5vo9DKFIBouWRDUVWFY= Page 21/32 (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb) [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
相似试验
进行中（未招募）
不适用
A study of LY2603618 with Pemetrexed and Cisplatin in patients with lung cancer• Histological diagnosis of Stage IV NSCLC other than predominantly squamous cell histology. • Mesothelioma in advanced or metastatic stage for whom the combination with pemetrexed and cisplatin is deemed to be appropriate. • Solid tumors with no other standard therapeutic option with =2previous systemic chemotherapies for their disease and a maximum of 6 cyclesof alkylating agents in all previous therapy settingsMedDRA version: 16.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-020408-31-DEEli Lilly and Company125
已完成
2 期
A Phase 1/Randomized Phase 2 Study to Evaluate LY2603618 in Combination with Gemcitabine in Patients with Pancreatic CancerPancreas adenocarcinoma10014713NL-OMON36787Eli Lilly15
进行中（未招募）
不适用
A Phase 1/Randomized Phase 2 Study to Evaluate LY2603618 in Combination with Gemcitabine in Patients with Pancreatic Cancer - JMMCPhase I: Patients with solid malignancy unlikely to benefit from approved therapies.Phase II: Patients with pancreatic cancer.EUCTR2008-006209-17-DEEli Lilly and Company149
进行中（未招募）
1 期
A study of LY2603618 with gemcitabine in patients with pancreatic cancerPhase I: Patients with solid malignancy unlikely to benefit from approved therapies.Phase II: Patients with pancreatic cancer.EUCTR2008-006209-17-SKEli Lilly and Company149
进行中（未招募）
不适用
A study of LY2603618 with gemcitabine in patients with pancreatic cancerPhase I: Patients with solid malignancy unlikely to benefit from approved therapies.Phase II: Patients with pancreatic cancer.MedDRA version: 14.0Level: LLTClassification code 10033612Term: Pancreatic carcinoma NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2008-006209-17-PLEli Lilly and Company149