Clinical Trial VICCGI1317
A Phase 2, Randomized, Multicenter Study of PEGPH20 (PEGylated Recombinant Human Hyaluronidase) Combined with nab-Paclitaxel Plus Gemcitabine Compared With nab-Paclitaxel Plus Gemcitabine in Subjects With Stage IV Previously Untreated Pancreatic Cancer
- Protocol No. VICCGI1317
- Open Date: 09/28/2013
- Staging: Phase II
- Age Group: Adults
- Scope: National
- Objective: To estimate the progression-free survival (PFS) duration of PEGPH20 combined with nab-paclitaxel (NAB) plus gemcitabine (GEM) (PAG treatment).
- Disease Sites: Pancreatic
- Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: Dexamethasone; Gemcitabine; Nab-paclitaxel; PEGPH20
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01839487
- Secondary Protocol No: HALO-109-202
Patients are being asked to participate in this study because they have been newly diagnosed with an advanced form of pancreatic cancer that has not been treated. There are two parts to this study. The purpose of both parts is to evaluate PEGPH20 at a dose of 3.0 -g/kg in combination with 2 chemotherapy drugs (a standard dose of gemcitabine plus a dose of nab-paclitaxel that has been tested in pancreatic cancer patients) versus gemcitabine and nab-paclitaxel alone (without PEGPH20). The first part (run-in phase) will study the safety and tolerability of these combinations. The second part (phase 2) will study the safety and efficacy (how well the drug works) of these combinations. The treatment in both phases will be almost the same.
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
CriteriaKey Inclusion Criteria:
• Signed Informed consent
• Histologically confirmed Stage IV pancreatic ductal adenocarcinoma w/ documented disseminated neoplasm to liver and /or lung. Must have archival or fresh tissue (block /slides) available pre-dose.
• One or more measurable metastatic tumors measurable on CT san per Response Evaluation Criteria in Solid Tumors (RECIST v.1.1 ).
• No previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease.
• Karnofsky Performance Status >= 70%
• Life expectancy >= 3 mos
• Age >= 18 years
• Screen labs of bilirubin,aspartate transaminase(AST), alanine transaminase(ALT), serum creatinine and albumin, absolute neutrophil count (ANC), hemoglobin, hematocrit and partial thromboplastin time(PTT) within specified values/criteria per protocol prior to dosing.
Key Exclusion Criteria:
• Non metastatic pancreatic ductal adenocarcinoma
• Known Central nervous system involvement, brain metastasis
• New York(NY) Heart Assoc Class III or IV cardiac disease or Myocardial infarction within the past 12 months.
• Active, uncontrolled bacterial, viral or fungal infection requiring systemic therapy.
• 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 or curatively-treated cervical cancer in-situ.
• Any other disease, metabolic dysfunction, physical examination finding or clinical lab 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 subject at a high risk of treatment complications.