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SCCA Clinical Studies: Phase 1 Program

PEGPH20 for Stage IV Previously Untreated Pancreatic Cancer (2542.00)
A Phase 1b/2 Multicenter, International, Randomized, Double Blind, Placebo-Controlled, Study of Gemcitabine (Gemzar) Combined With PEGPH20 Compared to Gemcitabine Combined With Placebo in Patients With Stage IV Previously Untreated Pancreatic Cancer
Status Conditions Phase Study ID
Closed Pancreatic Cancer Phase I/II 2542.00
NCT01453153
Summary

PEGPH20 is a PEGylated version of human recombinant PH20 hyaluronidase that, in preclinical studies, has been shown to remove HA from the extracellular matrix surrounding tumor cells by depolymerizing this substrate. 87% of pancreatic ductal adenocarcinomas (PDA) overexpress HA. PDA tumor tissue may be especially sensitive to the HA-degradation properties of PEGPH20 and thus more responsive to the cytotoxic effects of a given dose of gemcitabine. Modifying the extracellular environment to increase the penetration and efficacy of anti-cancer agents represents a novel approach to treating pancreatic cancer and may provide important therapeutic outcomes in patients with Stage IV Previously Untreated Pancreatic Cancer.

This Phase 1B/2 study will assess safety, tolerability, treatment effect, and various PK/PD endpoints.


Investigator
Sunil Hingorani, MD, PhD 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)
  • One or more metastatic tumors measurable on CT scan per RECIST 1.1 criteria
  • Patients with histologically confirmed Stage IV adenocarcinoma of the pancreas previously untreated for metastatic disease
  • Baseline CA19-9 of ≥ 100 U/mL in the absence of biliary obstruction or other physiological process unrelated to the tumor that may cause an elevation in CA19-9 levels
  • Life expectancy of at least 3 months
  • Signed, written IRB/EC-approved informed consent
  • A negative serum pregnancy test, if female
Exclusions (conditions that would prevent participation in this study)
  • New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 12 months, or cardiac arrhythmia requiring medical therapy
  • Known brain metastasis
  • Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
  • Known allergy to hyaluronidase
  • Women currently pregnant or breast feeding
Last Updated
September 27, 2013
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.