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