Study of Gemcitabine + PEGPH20 vs Gemcitabine Alone in Stage IV Previously Untreated Pancreatic Cancer
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Stage IV Pancreatic Cancer
In brief
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.
Key facts
- Study ID
- NCT01453153
- Run by
- Halozyme Therapeutics
- People needed
- 28
- Starts
- 2011-09-01
- Expected to finish
- 2015-05-01
- Last updated by the study team
- 2018-11-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Highlands Oncology Group — Fayetteville, Arkansas, United States
- California Pacific Medical Center — San Francisco, California, United States
- Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
- UMDNJ - New Jersey Medical School — Newark, New Jersey, United States
- NSLIJ Health System, Monter Cancer Center — New Hyde Park, New York, United States
- Mount Sinai School of Medicine — New York, New York, United States
- SUNY Upstate Medical University — Syracuse, New York, United States
- Seattle Cancer Care Alliance — Seattle, Washington, United States
- Chelyabinsk Regional Clinical Oncology Center — Chelyabinsk, Russia
- Russian Oncological Research Center n.a. N.N. Blokhin — Moscow, Russia
- Medical Radiological Research Center — Obninsk, Russia
- Omsk Regional Budget Medical Institution — Omsk, Russia
Full record on ClinicalTrials.gov
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