Status:
COMPLETED
PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Participants With Stage IV Untreated Pancreatic Cancer
Lead Sponsor:
Halozyme Therapeutics
Conditions:
Metastatic Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is designed to compare the treatment effect of PEGPH20 combined with nab-paclitaxel (NAB) and gemcitabine (GEM) \[PAG\] to NAB and GEM \[AG\] in participants with Stage IV previously untrea...
Eligibility Criteria
Inclusion
- Key
- Signed Informed consent.
- Histologically confirmed Stage IV PDA with documented disseminated neoplasm to liver and /or lung. Must have archival or fresh tissue (block /slides) available pre-dose.
- One or more metastatic tumors measurable on computed tomography (CT) scan per RECIST v.1.1 , excluding the primary pancreatic lesion.
- No previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease.
- Karnofsky Performance Status greater than or equal to (≥) 70%.
- Life expectancy ≥3 months.
- Age ≥18 years.
- Screening laboratory values of hemoglobin, platelets, absolute neutrophil count (ANC), bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), serum creatinine, serum albumin, prothrombin time/international normalized ratio (INR), and partial thromboplastin time (PTT) within specified values/criteria per protocol prior to dosing.
- Key
Exclusion
- Non-metastatic PDA.
- Evidence of deep vein thrombosis (DVT), pulmonary embolism (PE), or other known thromboembolic event present during screening period.
- Known central nervous system involvement or brain metastasis.
- New York (NY) Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months.
- Prior history of cerebrovascular accident or transient ischemic attack.
- Pre-existing carotid artery disease.
- Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy.
- Current use of megestrol acetate (use within 10 days of Day 1).
- Known infection with human immunodeficiency virus, Hepatitis B, or Hepatitis C.
- History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early state prostate cancer, or curatively-treated cervical cancer in-situ.
- Contraindication to heparin as per National Comprehensive Cancer Network (NCCN) guidelines.
- Previous major bleed (bleeding requiring transfusion of red blood cells) on low-molecular weight heparin (LMWH).
- Any other disease, metabolic dysfunction, physical examination finding or clinical laboratory finding that leads to reasonable suspicion of disease or condition that contraindicates the use of an investigational drug, that may affect interpretation of results, or render the participant at a high risk of treatment complications.
Key Trial Info
Start Date :
May 14 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2018
Estimated Enrollment :
279 Patients enrolled
Trial Details
Trial ID
NCT01839487
Start Date
May 14 2013
End Date
September 26 2018
Last Update
July 20 2020
Active Locations (51)
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1
Alabama Oncology
Birmingham, Alabama, United States, 35213
2
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States, 36604
3
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
4
Mayo Clinic - Scottsdale
Scottsdale, Arizona, United States, 85259