EUCTR2011-000211-64-BE进行中（未招募）1 期
A Phase 1b/2 Study with Gemcitabine and LY2157299 for Patients with Metastatic Cancer (Phase 1b) and Advanced or 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
- •Ph 2: 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.
- •Ph 2: 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 to RECIST
- •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 Group
- •Ph 2: 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
- •Ph1b & 2: 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 185
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 185
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 inhibitor.
- •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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