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Clinical Trials (PDQ®)

Study of Gemcitabine + PEGPH20 vs Gemcitabine Alone in Stage IV Previously Untreated Pancreatic Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase II, Phase IBiomarker/Laboratory analysis, TreatmentClosed18 and overPharmaceutical / IndustryHalo-109-201
NCT01453153

Trial Description

Summary

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.

Eligibility Criteria

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 Contact Information

Trial Lead Organizations/Sponsors

Halozyme Therapeutics

Joy H Zhu, MD, PhDStudy Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01453153
Information obtained from ClinicalTrials.gov on April 01, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.