EUCTR2011-000211-64-IT进行中（未招募）1 期
A Phase 1b/2 Study with Gemcitabine and LY2157299 forPatients with Metastatic Cancer (Phase 1b) and Advancedor Metastatic Unresectable Pancreatic Cancer (Phase 2)
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
- 150
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
- •Have 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. Patients with
- •previous radical surgery for pancreatic cancer are eligible after
- •progression is documented. If they received adjuvant chemotherapy or
- •chemoradiotherapy with gemcitabine, they can be enrolled if the
- •treatment was completed 3 months before or longer.
- •-Tumor tissue or unstained slides are available from original biopsy
- •or resection or other tumor biopsies.
- •Have measurable disease or non-measurable disease, defined according
- •- Males or females at least 18 years of age.
- •- Have given written informed consent prior to any study-specific procedures
- •- Have adequate organ function
- •- Have a performance status of =2 on the Eastern Cooperative Oncology
- •-Patients may have received previous adjuvant treatment with gemcitabine with or without radiotherapy for pancreatic cancer
- •Adjuvant treatment must have finished at least 6 months before enrolling
- •- patients must have recovered from any Grade 3/4 toxicities of previous therapies
- •Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
- •Prior radiation therapy for treatment of cancer is allowed to <25% of the
- •bone marrow (Cristy and Eckerman 1987), 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. Prior
- •radiotherapy must be completed at least 4 weeks before study entry.
- •Male and female patients with reproductive potential must use an
- •approved contraceptive method, if appropriate, during and for 3 months
- •after discontinuation of study treatment.
- •Women of childbearing potential must have a negative beta-human
- •chorionic gonadotropin pregnancy test documented within 14 days prior
- •to treatment. If condoms are used as a barrier contraceptive, a
- •spermicidal agent should be added to ensure that pregnancy does not
- •occur. Should a woman become pregnant or suspect she is pregnant
- •while participating in this study, she should inform her treating
- •physician immediately.
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •Patients will be excluded from the study if they meet any of the
- •following criteria:
- •Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or nonapproved use of a drug or device (other than the investigational product used in this study), or concurrently enrolled in any other type of medical research
- •judged not to be scientifically or medically compatible with this study.
- •Have moderate or severe cardiac disease
- •Are unable to swallow tablets or capsules.
- •Are pregnant or breastfeeding.
- •Have any significant medical illnesses that, in the investigator's opinion,
- •cannot be adequately controlled with appropriate therapy or would
- •compromise the patient?s ability to tolerate this therapy.
- •Have a history of any other cancer (except non-melanoma skin cancer or
- •carcinoma in-situ), unless in complete remission and off of all therapy
- •for that disease for a minimum of 3 years.
- •Have active infection that would interfere with the study objectives or
- •influence study compliance.
- •Endocrine pancreatic tumors or ampullary cancer.
- •Patients with acute or chronic leukemia or with any other disease likely to have a significant bone marrow infiltration (screening not required).
- •Have previously completed or withdrawn from this study or any other
- •study investigating LY2157299 monohydrate or any other TGF-ß
- •Have known allergy to LY2157299 monohydrate or gemcitabine or any
- •ingredient of LY2157299 monohydrate or gemcitabine formulations.
- •Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse,parent, child, or sibling, whether biological or legally adopted.
研究者
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