Study of Gemcitabine + PEGPH20 vs Gemcitabine Alone in Stage IV Previously Untreated Pancreatic Cancer
NCT ID: NCT01453153
Last Updated: 2018-11-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
28 participants
INTERVENTIONAL
2011-09-30
2015-05-31
Brief Summary
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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.
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Detailed Description
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This Phase 1B/2 study will assess safety, tolerability, treatment effect, and various PK/PD endpoints.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Gemcitabine
Gemcitabine + Placebo
Gemcitabine
1000 mg/m2 given IV one time a week (Cycle 1: 7 weeks on treatment, 1 week off treatment; Cycle 2+: 3 Weeks on treatment, 1 week off treatment)
Placebo
(Cycle 1: 7 weeks on treatment/1 week off treatment; Cycle 2+: 3 Weeks on treatment/1 week off treatment).
PEGPH20
PEGPH20+Gemcitabine
Gemcitabine
1000 mg/m2 given IV one time a week (Cycle 1: 7 weeks on treatment, 1 week off treatment; Cycle 2+: 3 Weeks on treatment, 1 week off treatment)
PEGPH20
(Cycle 1: 7 weeks on treatment/1 week off treatment; Cycle 2+: 3 Weeks on treatment/1 week off treatment). Doses start at 1.0 mcg/kg and modified until recommended Phase 2 dose is determined. Treatment continues until occurrence of significant treatment-related toxicity, progressive disease, or discontinuation criteria are met
Interventions
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Gemcitabine
1000 mg/m2 given IV one time a week (Cycle 1: 7 weeks on treatment, 1 week off treatment; Cycle 2+: 3 Weeks on treatment, 1 week off treatment)
PEGPH20
(Cycle 1: 7 weeks on treatment/1 week off treatment; Cycle 2+: 3 Weeks on treatment/1 week off treatment). Doses start at 1.0 mcg/kg and modified until recommended Phase 2 dose is determined. Treatment continues until occurrence of significant treatment-related toxicity, progressive disease, or discontinuation criteria are met
Placebo
(Cycle 1: 7 weeks on treatment/1 week off treatment; Cycle 2+: 3 Weeks on treatment/1 week off treatment).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Halozyme Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Joy H Zhu, MD, PhD
Role: STUDY_DIRECTOR
Halozyme Therapeutics
Locations
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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
Countries
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Other Identifiers
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Halo-109-201
Identifier Type: -
Identifier Source: org_study_id
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