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

Halozyme, Inc.0 个研究点目标入组 420 人开始时间: 2016年3月18日最近更新: 2019年12月16日

试验速览

暂无简介。

•1. Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form (ICF).
•2. Stage IV pancreatic ductal adenocarcinoma (PDA) with histological confirmation of PDA via archived or fresh core biopsy of either the primary tumor or 1 metastatic in minimum of 5-10 unstained core biopsy slides that meet specific tissue sample requirements are required.
•3. Subjects must be determined to be HA-high based on tumor biopsy that meets the requirements noted in inclusion criteria #2.
•4. If a subject has had adjuvant therapy (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 adjuvant therapy, provided all toxicities have returned to baseline or < = Grade 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 189
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 231

•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. Pre-existing carotid artery disease.

发起方