EUCTR2015-004068-13-DE进行中（未招募）1 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus nab-Paclitaxel and Gemcitabine in Subjects with Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma
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
- 500
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. Signed, written Institutional Review Board/Ethics Committee approved Informed Consent Form (ICF).
- •2. Stage IV PDA with histological or cytological confirmation of PDA
- •3. Subjects must be determined to be HA-high based on archived or fresh tumor core biopsy or sample obtained after the subject has documented metastatic disease. Biopsies/samples must meet the following requirements:
- •a. Pancreas tumor biopsies/samples obtained on or after the date that metastatic disease is documented or tumor biopsies/samples from a metastatic lesion are acceptable.
- •b. Tumor biopsies or samples must meet the requirements provided in the Study Laboratory Manual with regard to tumor tissue architecture.
- •Note: cytology samples from fine needle aspirates without maintained
- •tissue architecture or brushing biopsies are not acceptable.
- •c. Tumor tissue (formalin-fixed paraffin-embedded [FFPE] block preferred) must include enough tumor to make a minimum of 5-10 unstained, consecutive FFPE slides (10 slides are preferred) of 1 archival block that meet specific tissue sample requirements (see Study Laboratory Manual). Radiographic confirmation.
- •4. Radiographic confirmation of Stage IV PDA with at least 1 tumor metastasis measurable on CT scan or MRI per RECIST version 1.1 criteria, excluding the primary pancreatic lesion.
- •5. If a subject has had adjuvant/neoadjuvant therapy and/or therapy for locally advanced disease (chemotherapy for non-metastatic pancreatic cancer in combination with or without radiation therapy), tumor recurrence or disease progression must have occurred no sooner than 6 months after completing the last dose of the aforementioned therapies, provided all toxicities have returned to baseline or = Grade 1.
- •6. Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- •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 253
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 247
排除标准
- •1. Clinical evidence of DVT, PE or other known TE event present during the screening period.
- •2. Previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease.
- •a. Palliative radiotherapy for pain control of metastatic bone lesions is allowed.
- •3. Known central nervous system involvement or brain metastases.
- •4. New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months.
- •5. History of cerebrovascular accident or transient ischemic attack.
- •6. Clinically significant pre-existing carotid artery disease.
研究者
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