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SCCA Clinical Studies: Phase 1 Program

PEGPH20 for Stage IV Untreated Pancreatic Cancer (2687)
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
Status Conditions Phase Study ID
Recruiting Metastatic Pancreatic Cancer Phase II 2687
NCT01839487
Summary

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. Phase 2 (safety and treatment effect), 124 subjects, 1:1 ratio, PAG:AG, preceded by 8 subject Run-In phase (safety and tolerability).


Investigator
Sunil R. Hingorani, MD William P. Harris, MD
Location    
SCCA Phase 1 Program Office 206-288-7551 Refer Patient
Eligibility Criteria (must meet the following to participate in this study)
  • 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.
Exclusions (conditions that would prevent participation in this study)
  • 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.
Last Updated
August 15, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.