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
18 Years
N/A
Both
Stage IV Pancreatic Cancer
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
To determine the safe dose of PEGPH20 in combination with the approved dose of gemcitabine.
Outcome Description:
The safety and tolerability profile of PEGPH20 used in combination with gemcitabine will be assessed.
Outcome Time Frame:
1 year
Safety Issue:
Yes
Principal Investigator
Joy H Zhu, MD, PhD
Investigator Role:
Study Director
Investigator Affiliation:
Halozyme, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
Halo-109-201
NCT ID:
NCT01453153
Start Date:
September 2011
Completion Date:
December 2013
Related Keywords:
- Stage IV Pancreatic Cancer
- pancreatic
- Cancer
- Stage IV
- untreated
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Mount Sinai School of Medicine | New York, New York 10029 |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
| Seattle Cancer Care Alliance | Seattle, Washington 98109 |
| Highlands Oncology Group | Springdale, Arkansas 72764 |
| SUNY Upstate Medical University | Syracuse, New York 13210 |
| California Pacific Medical Center | San Francisco, California 94115 |
| UMDNJ - New Jersey Medical School | Newark, New Jersey 07103 |
| NSLIJ Health System, Monter Cancer Center | New Hyde Park, New York 11040 |
