Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma MedDRA version: 20.0 Level: LLT Classification code 10007050 Term: Cancer System Organ Class: 100000004864
Conditions
Interventions
Product Name: PEGylated Recombinant Human Hyaluronidase
Product Code: PEGPH20
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Proposed I
Sponsors
Halozyme, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. Of Stage IV PDA with at least 1 tumor metastasis measurable on CT scan and/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 189 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 231
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To determine the PFS benefit of PEGPH20 combined with nab-paclitaxel (NAB) plus gemcitabine (GEM) (PAG treatment), compared with placebo plus NAB/GEM (AG treatment), in subjects with hyaluronan (HA)-high Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA) • To determine the overall survival (OS) benefit of PAG treatment, compared with AG treatment, in subjects with HA-high Stage IV previously untreated PDA ; Secondary Objective: • To determine the objective response rate (ORR) and duration of response (DOR) of PAG treatment, compared with AG treatment, in subjects with HA-high Stage IV previously untreated PDA • To assess the safety and tolerability of PAG treatment in subjects with HA-high Stage IV previously untreated PDA ; Primary end point(s): • Progression-free survival • Overall survival ; Timepoint(s) of evaluation of this end point: Final PFS will be conducted at the interim when a pre-specified number of PFS events have occurred. Final OS analysis will be conducted at the end of the study. During long-term follow-up information on the subject's survival and subsequent anticancer therapy will be obtained by the site monthly until the subject dies, is lost to follow-up, or withdraws consent. Subjects will be censored for OS at the time of the last "known alive" contact. The OS analysis will be conducted at the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Objective response rate • Duration of response • Incidence of AEs, changes in clinical safety laboratory values, and changes in cardiovascular parameters (electrocardiogram [ECG] and vital signs) ;Timepoint(s) of evaluation of this end point: Refer to protocol for information. | — |
Countries
Australia, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, Poland, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactHalozyme Study Information
Halozyme, Inc.
Outcome results
None listed