PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Subjects With Stage IV Untreated Pancreatic Cancer

Status: Recruiting
Phase: Phase 2
Diagnosis: Gastrointestinal Malignancies
NCT ID: NCT01839487 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-279

 

To compare the treatment effect of PEGPH20 combined with nab-paclitaxel and gemcitabine (PAG) to nab-paclitaxel and gemcitabine (AG) in subjects with Stage IV pancreatic cancer. The Phase 2 will study safety and treatment effect in 237 subjects (2:1 randomization, PAG:AG), preceded by two run-in phases (the first to assess safety and tolerability and a second to assess a new formulation of PEGHP20), 16 subjects total (randomized 3:1).

 

Conducting Institutions:
Beth-Israel Deaconess Medical Center

Overall PI:
Andrea Bullock, M.D., Beth Israel Deaconess Medical Center

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Gastrointestinal Research Line, 617-632-5960

Eligibility Criteria

Key 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.
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