Overview

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

Status:
Completed
Trial end date:
2015-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Halozyme Therapeutics
Treatments:
Gemcitabine
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