PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Participants With Stage IV Untreated Pancreatic Cancer
NCT ID: NCT01839487
Last Updated: 2020-07-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
279 participants
INTERVENTIONAL
2013-05-14
2018-09-26
Brief Summary
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The study will have 2 run-in phases, one for each formulation of PEGPH20 (original and new formulations), and a Phase 2 portion. The 2 run-in phases will evaluate the safety and tolerability of the PAG treatment using the original and new succinic acid PEGPH20 formulation, respectively, compared with AG treatment. Phase 2 will have 2 stages due to a partial clinical hold that occurred from April through July 2014. The participants will be randomized in 3:1 for the run-in phases. The first stage will randomize participants in a 1:1 ratio. The second stage will randomize participants in a 2:1 ratio (PAG:AG).
This is an open-label study. To minimize bias to the progression-free survival endpoint, disease progression will be based on the assessment of the Central Imaging Reader (CIR). Determination of clinical progression by the Investigator without corresponding CIR confirmation will be documented with the relevant signs and symptoms.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Run-in Phase - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine
Participants will receive 3.0 micrograms/kilogram (mcg/kg) PEGPH20 with 125 milligrams/square meter (mg/m\^2) NAB and 1000 mg/m\^2 GEM as intravenous (IV) infusion. In Cycle 1 Week 1, PEGPH20 will be administered alone on Days 1 and 4 and NAB+GEM will be given on Day 2 at approximately 24 hours after first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 will be given twice/week on Days 8, 11, 15 and 18 and NAB+GEM will be given once/week at 2 to 4 hours after PEGPH20 administration on Days 8 and15. In Cycle 2 onwards, PEGPH20, NAB, and GEM will be given once/week on Days 1 8 and 15. NAB+GEM will be given 2 to 4 hours after PEGPH20 dose. Each cycle will be of 4-weeks with Week 4 of every cycle as a rest week (no treatment will be given). Treatment will continue until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg will be given in each cycle within 2 hours prior and 8 to 12 hours after completion of each PEGPH20 infusion.
PEGPH20
PEGPH20 will be administered as per the dose and schedule specified in the respective arms.
Nab-paclitaxel
Nab-paclitaxel will be administered as per the dose and schedule specified in the respective arms.
Gemcitabine
Gemcitabine will be administered as per the dose and schedule specified in the respective arms.
Dexamethasone
Dexamethasone will be administered as per the dose and schedule specified in the respective arms.
Run-in Phase - AG: Nab-paclitaxel + Gemcitabine
Participants will receive 125 mg/m\^2 NAB and 1000 mg/m\^2 GEM, as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle will be of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment will be given). Treatment will continue until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg will be given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion.
Nab-paclitaxel
Nab-paclitaxel will be administered as per the dose and schedule specified in the respective arms.
Gemcitabine
Gemcitabine will be administered as per the dose and schedule specified in the respective arms.
Dexamethasone
Dexamethasone will be administered as per the dose and schedule specified in the respective arms.
Phase 2: Stage 1 - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine
Participants will receive 3.0 mcg/kg PEGPH20 with 125 mg/m\^2 NAB and 1000 mg/m\^2 GEM as an IV infusion. In Cycle 1 Week 1, PEGPH20 will be given alone on Days 1 and Day 4 and NAB+GEM will be given on Day 2 at approximately 24 hours after first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 will be given twice/week on Days 8, 11, 15, and 18 and NAB+GEM will be given once/week at 2 to 4 hours after PEGPH20 administration on Days 8 and 15. In Cycle 2 onwards, PEGPH20, NAB, and GEM will be given once/week on Days 1, 8, and 15. NAB+GEM will be given 2 to 4 hours after dose of PEGPH20. Each cycle will be of 4-weeks with Week 4 of every cycle as a rest week (no treatment will be given). Treatment will continue until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg will be given in each cycle within 2 hours prior to the beginning and 8 to 12 hours after the completion of each PEGPH20 infusion.
PEGPH20
PEGPH20 will be administered as per the dose and schedule specified in the respective arms.
Nab-paclitaxel
Nab-paclitaxel will be administered as per the dose and schedule specified in the respective arms.
Gemcitabine
Gemcitabine will be administered as per the dose and schedule specified in the respective arms.
Dexamethasone
Dexamethasone will be administered as per the dose and schedule specified in the respective arms.
Phase 2: Stage 1 - AG: Nab-paclitaxel + Gemcitabine
Participants will receive 125 mg/m\^2 NAB and 1000 mg/m\^2 GEM as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle will be of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment will be given). Treatment will continue until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg will be given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion.
Nab-paclitaxel
Nab-paclitaxel will be administered as per the dose and schedule specified in the respective arms.
Gemcitabine
Gemcitabine will be administered as per the dose and schedule specified in the respective arms.
Dexamethasone
Dexamethasone will be administered as per the dose and schedule specified in the respective arms.
Phase 2: Stage 2 - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine
Participants will receive 3.0 mcg/kg PEGPH20 with 125 mg/m\^2 NAB and 1000 mg/m\^2 GEM as an IV infusion. In Cycle 1 Week 1, PEGPH20 will be given alone on Days 1 and 4 and NAB+GEM will be given on Day 2 at approximately 24 hours after first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 will be given twice/week on Days 8, 11, 15, and 18 and NAB+GEM will be given once/week at 2 to 4 hours after PEGPH20 administration on Days 8 and 15. In Cycle 2 onwards, PEGPH20, NAB, and GEM will be given once/week on Days 1, 8, and 15. NAB+GEM will be given 2 to 4 hours after dose of PEGPH20. Each cycle will be of 4-weeks with Week 4 of every cycle as a rest week (no treatment will be given). Treatment will continue until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg will be given in each cycle within 2 hours prior to beginning and 8 to 12 hours after completion of each PEGPH20 infusion. Enoxaparin 40 mg/day or 1 mg/kg/day will be given subcutaneously (SC).
PEGPH20
PEGPH20 will be administered as per the dose and schedule specified in the respective arms.
Nab-paclitaxel
Nab-paclitaxel will be administered as per the dose and schedule specified in the respective arms.
Gemcitabine
Gemcitabine will be administered as per the dose and schedule specified in the respective arms.
Dexamethasone
Dexamethasone will be administered as per the dose and schedule specified in the respective arms.
Enoxaparin
Enoxaparin will be administered as per the dose and schedule specified in the respective arms.
Phase 2: Stage 2 - AG: Nab-paclitaxel + Gemcitabine
Participants will receive 125 mg/m\^2 NAB and 1000 mg/m\^2 GEM as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle will be of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment will be given). Treatment will continue until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg will be given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion. Enoxaparin 40 mg/day or 1 mg/kg/day will be given SC.
Nab-paclitaxel
Nab-paclitaxel will be administered as per the dose and schedule specified in the respective arms.
Gemcitabine
Gemcitabine will be administered as per the dose and schedule specified in the respective arms.
Dexamethasone
Dexamethasone will be administered as per the dose and schedule specified in the respective arms.
Enoxaparin
Enoxaparin will be administered as per the dose and schedule specified in the respective arms.
Interventions
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PEGPH20
PEGPH20 will be administered as per the dose and schedule specified in the respective arms.
Nab-paclitaxel
Nab-paclitaxel will be administered as per the dose and schedule specified in the respective arms.
Gemcitabine
Gemcitabine will be administered as per the dose and schedule specified in the respective arms.
Dexamethasone
Dexamethasone will be administered as per the dose and schedule specified in the respective arms.
Enoxaparin
Enoxaparin will be administered as per the dose and schedule specified in the respective arms.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed Stage IV PDA with documented disseminated neoplasm to liver and /or lung. Must have archival or fresh tissue (block /slides) available pre-dose.
* One or more metastatic tumors measurable on computed tomography (CT) scan per RECIST v.1.1 , excluding the primary pancreatic lesion.
* No previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease.
* Karnofsky Performance Status greater than or equal to (≥) 70%.
* Life expectancy ≥3 months.
* Age ≥18 years.
* Screening laboratory values of hemoglobin, platelets, absolute neutrophil count (ANC), bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), serum creatinine, serum albumin, prothrombin time/international normalized ratio (INR), and partial thromboplastin time (PTT) within specified values/criteria per protocol prior to dosing.
Exclusion Criteria
* Evidence of deep vein thrombosis (DVT), pulmonary embolism (PE), or other known thromboembolic event present during screening period.
* Known central nervous system involvement or brain metastasis.
* New York (NY) Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months.
* Prior history of cerebrovascular accident or transient ischemic attack.
* Pre-existing carotid artery disease.
* Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy.
* Current use of megestrol acetate (use within 10 days of Day 1).
* Known infection with human immunodeficiency virus, Hepatitis B, or Hepatitis C.
* History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early state prostate cancer, or curatively-treated cervical cancer in-situ.
* Contraindication to heparin as per National Comprehensive Cancer Network (NCCN) guidelines.
* Previous major bleed (bleeding requiring transfusion of red blood cells) on low-molecular weight heparin (LMWH).
* Any other disease, metabolic dysfunction, physical examination finding or clinical laboratory finding that leads to reasonable suspicion of disease or condition that contraindicates the use of an investigational drug, that may affect interpretation of results, or render the participant at a high risk of treatment complications.
18 Years
ALL
No
Sponsors
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Halozyme Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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VP, Clinical Development
Role: STUDY_DIRECTOR
Halozyme Therapeutics
Locations
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Alabama Oncology
Birmingham, Alabama, United States
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Mayo Clinic - Scottsdale
Scottsdale, Arizona, United States
Arizona Oncology Associates, PC
Tucson, Arizona, United States
Highlands Oncology Group
Fayetteville, Arkansas, United States
Providence St Joseph Medical Center
Burbank, California, United States
Scripps Cancer Center
La Jolla, California, United States
UCSD - Moore's Cancer Center
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California Medical Center
Orange, California, United States
Pacific Hematology Oncology Associates
San Francisco, California, United States
Saint Helena Hospital
St. Helena, California, United States
The Oncology Institute of Hope and Innovation
Whittier, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
Stamford Hospital
Stamford, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
University of Miami, Sylvester comprehensive Cancer Center
Miami, Florida, United States
H. Lee Moffit Cancer Center
Tampa, Florida, United States
Piedmont Hospital
Atlanta, Georgia, United States
Loyola University Medical Center
Maywood, Illinois, United States
Norton Cancer Institute - Norton HealthCare Pavilion
Louisville, Kentucky, United States
Johns Hopkins University Hospital
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Lahey Clinic
Burlington, Massachusetts, United States
University of Mass Medical School
Worcester, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
Unniversity of Minnesota
Minneapolis, Minnesota, United States
Research Medical Center
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
St. Joseph's Regional Medical Center
Paterson, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
North Shore Long Island Jewish Health System
Lake Success, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Gabrail Cancer Center
Canton, Ohio, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States
UPMC Cancer Center
Pittsburgh, Pennsylvania, United States
Greenville Health System
Greenville, South Carolina, United States
Texas Oncology - Baylor
Dallas, Texas, United States
Cancer Care Centers of South Texas
New Braunfels, Texas, United States
Texas Oncology
Tyler, Texas, United States
Columbia Basin Hematology and Oncology
Kennewick, Washington, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
NorthWest Medical Specialties, PLLC
Tacoma, Washington, United States
University of Wisconsin Hospitals and Clinics
Madison, Wisconsin, United States
Froedtert Hospital, Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Hingorani SR, Zheng L, Bullock AJ, Seery TE, Harris WP, Sigal DS, Braiteh F, Ritch PS, Zalupski MM, Bahary N, Oberstein PE, Wang-Gillam A, Wu W, Chondros D, Jiang P, Khelifa S, Pu J, Aldrich C, Hendifar AE. HALO 202: Randomized Phase II Study of PEGPH20 Plus Nab-Paclitaxel/Gemcitabine Versus Nab-Paclitaxel/Gemcitabine in Patients With Untreated, Metastatic Pancreatic Ductal Adenocarcinoma. J Clin Oncol. 2018 Feb 1;36(4):359-366. doi: 10.1200/JCO.2017.74.9564. Epub 2017 Dec 12.
Wang S, Bager CL, Karsdal MA, Chondros D, Taverna D, Willumsen N. Blood-based extracellular matrix biomarkers as predictors of survival in patients with metastatic pancreatic ductal adenocarcinoma receiving pegvorhyaluronidase alfa. J Transl Med. 2021 Jan 21;19(1):39. doi: 10.1186/s12967-021-02701-z.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Reflects interim analysis conducted on mature data when 95% of participants had discontinued from the study.
Other Identifiers
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HALO-109-202
Identifier Type: -
Identifier Source: org_study_id
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