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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Halozyme Therapeutics
ClinicalTrials.gov Identifier:
NCT01453153
First received: October 13, 2011
Last updated: September 25, 2013
Last verified: September 2013

October 13, 2011
September 25, 2013
September 2011
November 2013   (final data collection date for primary outcome measure)
  • To determine the safe dose of PEGPH20 in combination with the approved dose of gemcitabine. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    The safety and tolerability profile of PEGPH20 used in combination with gemcitabine will be assessed.
  • To compare the effect of overall survival between treatment groups. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To compare the effect of overall survival of gemcitabine plus PEGPH20 vs gemcitabine plus placebo in Stage IV previously untreated pancreatic cancer patients.
Same as current
Complete list of historical versions of study NCT01453153 on ClinicalTrials.gov Archive Site
  • To characterize plasma PK of PEGPH20 when used in combination with gemcitabine [ Time Frame: Multiple visits and timepoints for the duration of the study ] [ Designated as safety issue: No ]
    Evaluation of plasma PK
  • Assess the ORR by RECIST 1.1 criteria [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Assess PEGPH20 PD activities including HA catabolites in serum and urine, HA staining changes in tumor biopsies, as well as PEGPH20 effect on vascular perfusion and metabolic activities of the tumor using DCE MRI and FDG PET [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Explore the PEGPH20 effect on CA19-9 changes in relation to: 1. Intensity of tumor-associated HA staining 2. DCE-MRI perfusion, and/or 3. FDG-PEG/CT perfusion, anatomic data and metabolic activity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Study of Gemcitabine + PEGPH20 vs Gemcitabine Alone in Stage IV Previously Untreated Pancreatic Cancer
A Phase 1b/2 Multicenter, International, Randomized, Double Blind, Placebo-Controlled, Study of Gemcitabine Combined With PEGPH20 Compared to Gemcitabine Combined With Placebo in Patients With Stage IV Previously Untreated Pancreatic Cancer

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Stage IV Pancreatic Cancer
  • Drug: Gemcitabine
    1000 mg/m2 given IV one time a week (Cycle 1: 7 weeks on treatment, 1 week off treatment; Cycle 2+: 3 Weeks on treatment, 1 week off treatment)
    Other Name: Gemzar
  • Drug: PEGPH20+ gemcitabine
    (Cycle 1: 7 weeks on treatment/1 week off treatment; Cycle 2+: 3 Weeks on treatment/1 week off treatment). Doses start at 1.0 mcg/kg and modified until recommended Phase 2 dose is determined. Gemcitabine given at 1000mg/m2. Treatment continues until occurrence of significant treatment-related toxicity, progressive disease, or discontinuation criteria are met
    Other Name: PEGylated Recombinant Human Hyaluronidase
  • Active Comparator: Gemcitabine
    Gemcitabine + Placebo
    Intervention: Drug: Gemcitabine
  • Experimental: PEGPH20
    PEGPH20+Gemcitabine
    Intervention: Drug: PEGPH20+ gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
147
December 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Russian Federation
 
NCT01453153
Halo-109-201
No
Halozyme Therapeutics
Halozyme Therapeutics
Not Provided
Study Director: Joy H Zhu, MD, PhD Halozyme, Inc.
Halozyme Therapeutics
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP