PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Subjects With Stage IV Untreated Pancreatic Cancer
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).
Beth-Israel Deaconess Medical Center
Andrea Bullock, M.D.,
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute:
Gastrointestinal Research Line, 617-632-5960
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.