Status:
COMPLETED
Study of Gemcitabine + PEGPH20 vs Gemcitabine Alone in Stage IV Previously Untreated Pancreatic Cancer
Lead Sponsor:
Halozyme Therapeutics
Conditions:
Stage IV Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01453153
Start Date
September 1 2011
End Date
May 1 2015
Last Update
November 30 2018
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72707
2
California Pacific Medical Center
San Francisco, California, United States, 94120
3
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
4
UMDNJ - New Jersey Medical School
Newark, New Jersey, United States, 07103