|Phase II, Phase I||Biomarker/Laboratory analysis, Treatment||Closed||18 and over||Pharmaceutical / Industry||Halo-109-201|
Phase 1B: Open label (all patients receive PEGPH20+gemcitabine), dose escalation, safety and tolerability study to determine the safe dose of PEGPH20 to use in combination with gemcitabine in Stage IV previously untreated pancreatic cancer patients.
Phase 2: Randomized, double blind study to compare the effect of overall survival of gemcitabine plus PEGPH20 vs gemcitabine plus placebo in Stage IV previously untreated pancreatic cancer patients.
Further Study Information
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.
Key Inclusion Criteria:
- Patients with histologically confirmed Stage IV adenocarcinoma of the pancrease previously untreated for metastatic disease
- One or more metastatic tumors measurable on CT scan per RECIST 1.1 criteria
- Life expectancy of at least 3 months
- Signed, written IRB/EC-approved informed consent
- A negative serum pregnancy test, if female
Key Exclusion Criteria:
- Known brain metastasis
- New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 12 months
- Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
- Known allergy to hyaluronidase
- Women currently pregnant or breast feeding
Trial Lead Organizations/Sponsors
|Joy H Zhu, MD, PhD||Study Director|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01453153
Information obtained from ClinicalTrials.gov on April 01, 2013
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