Study investigating PEGylated Recombinant Human Hyaluronidase (PEGPH20) in previously untreated patients with pancreatic cancer that have high levels of hyaluronan. The study has two groups: all patients will be treated with nab-Paclitaxel plus Gemcitabine. In addition, one group will receive PEGPH20 and the other group will receive an inactive substance. Neither the patient nor the doctor will know the treatment group in which the patient has been randomly assigned to.
- Conditions
- Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal AdenocarcinomaMedDRA version: 18.1 Level: LLT Classification code 10007050 Term: Cancer System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-004068-13-ES
- Lead Sponsor
- Halozyme, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 420
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method