Trial record 1 of 1 for:    NCT01839487
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PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Subjects With Stage IV Untreated Pancreatic Cancer (HALO-109-202)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01839487
Recruitment Status : Completed
First Posted : April 25, 2013
Last Update Posted : October 18, 2018
Information provided by (Responsible Party):
Halozyme Therapeutics

Brief Summary:

To compare the treatment effect of PEGPH20 combined with nab-paclitaxel and gemcitabine (PAG) to nab-paclitaxel and gemcitabine (AG) in subjects with Stage IV pancreatic cancer.

The Phase 2 will study safety and treatment effect in 237 subjects (2:1 randomization, PAG:AG), preceded by two run-in phases (the first to assess safety and tolerability and a second to assess a new formulation of PEGHP20), 16 subjects total (randomized 3:1).

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Cancer Drug: PEGPH20+nab-paclitaxel+gemcitabine Drug: nab-paclitaxel + gemcitabine Phase 2

Detailed Description:
  1. Phase 2, multicenter open-label randomized study with two run-in phases. The first run-in phase was to evaluate safety and tolerability of PEGPH20 + Nab-paclitaxel + Gemcitabine vs. Nab-paclitaxel + Gemcitabine. A second run-in phase was to evaluate a new formulation of PEGPH20.

    Phase 2 will be an open-label randomized study with same study drugs evaluating safety and efficacy.

  2. Subjects must have newly diagnosed stage 4 untreated metastatic pancreatic ductal cancer diagnosed by a standard of Care CT scan within 20 days of dosing and meet all inclusion/exclusion criteria.
  3. Treatment consists of 4 week treatment cycles with Week 4 of every cycle, a wash-out week. In Cycle 1, PEGPH20 will be administered twice per week with Nab-paclitaxel + Gemcitabine given once/week 2-4 hrs after PEGPH20 and nab-paclitaxel + gemcitabine alone
  4. Safety parameters include medical history, physical exams, adverse event and Concomitant med collection, Doppler and CT scans for thromboembolic events, prophylactic enoxaparin, Karnofsky Performance scale, Immunogenicity, Hematology, Chemistry, coagulation, Weight/body surface area (BSA) for dosing, ECG and pharmacokinetics (PK) and Hyaluronan (HA) catabolite levels. Efficacy parameters include standard of care CT scans, CA19-9, tumor analysis of HA.
  5. Subjects continue in study until disease progression, adverse event/toxicity, death or either the subject/sponsor discontinues the study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 279 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Multicenter Study of PEGPH20 (PEGylated Recombinant Human Hyaluronidase)Combined With Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Subjects With Stage IV Previously Untreated Pancreatic Cancer
Study Start Date : April 2013
Actual Primary Completion Date : May 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: PEGPH20
Drug: PEGPH20+nab-paclitaxel+gemcitabine
PEGPH20 3ug/kg + nab-paclitaxel 125 mg/m2 + gemcitabine 1000 mg/m2. PEGPH20 given IV x2/week for Cycle 1 and weekly for Cycle 2 and beyond. Nab-paclitaxel and gemcitabine given IV x1/week for 3 weeks for all cycles.
Other Names:
  • Abraxane
  • Gemzar

Active Comparator: nab-paclitaxel + gemcitabine
nab-paclitaxel + gemcitabine x1/week
Drug: nab-paclitaxel + gemcitabine
nab-paclitaxel 125 mg/m2 + gemcitabine 1000 mg/m2 given IV x1/week 3/4 weeks per cycle
Other Names:
  • Abraxane
  • Gemzar

Primary Outcome Measures :
  1. Estimate the PFS duration of PEGPH20 combined with NAB plus GEM [ Time Frame: 12 months ]
  2. To evaluate the thromboembolic events in subjects treated in the PAG arm [ Time Frame: Ongoing ]

Secondary Outcome Measures :
  1. Estimate relative benefit of PAG treatment vs. AG treatment, as assessed by the PFS ratio [ Time Frame: 1 year ]
  2. Estimate relative benefit of PAG vs AG treatment as assessed by the PFS hazard ratio based on subject tumor-associated HA levels [ Time Frame: 1 year ]
  3. Estimate ORR as defined by RECIST 1.1 of PAG treatment and the relative benefit of PAG treatment vs AG treatment [ Time Frame: 1 year ]
  4. To estimate the OS duration of PAG treatment and the relative benefit of PAG treatment vs AG treatment, as assessed by the OS hazard ratio. [ Time Frame: 16 months ]
  5. To evaluate the safety and tolerability profile of PAG and AG treatment groups [ Time Frame: 1 year ]
  6. To characterize the plasma PK of PEGPH20 when given in combination with NAB + GEM [ Time Frame: Various visits and timepoints ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  • Signed Informed consent
  • Histologically confirmed Stage IV pancreatic ductal adenocarcinoma w/ documented disseminated neoplasm to liver and /or lung. Must have archival or fresh tissue (block /slides) available pre-dose.
  • One or more measurable metastatic tumors measurable on CT san per Response Evaluation Criteria in Solid Tumors (RECIST v.1.1 ), excluding the primary lesion.
  • No previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease.
  • Karnofsky Performance Status >= 70%
  • Life expectancy >= 3 mos
  • Age >= 18 years
  • Screen labs of Hemoglobin, platelets, absolute neutrophil count (ANC), bilirubin, AST, ALT, serum creatinine, serum albumin, PT/INR, and PTT within specified values/criteria per protocol prior to dosing.

Key Exclusion Criteria:

  • Non metastatic pancreatic ductal adenocarcinoma
  • Evidence of deep vein thrombosis (DVT) or pulmonary embolism (PE) or other known thromboembolic event present during screening period.
  • Known Central nervous system involvement, 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 NCCN guidelines
  • Previous major bleed (bleeding requiring transfusion of red blood cells) on LMWH
  • Any other disease, metabolic dysfunction, physical examination finding or clinical lab 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 subject at a high risk of treatment complications.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01839487

  Hide Study Locations
United States, Alabama
Alabama Oncology
Birmingham, Alabama, United States, 35213
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States, 36604
United States, Arizona
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Mayo Clinic - Scottsdale
Scottsdale, Arizona, United States, 85259
Arizona Oncology Associates, PC
Tucson, Arizona, United States, 85704
United States, Arkansas
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
United States, California
Providence St Joseph Medical Center
Burbank, California, United States, 91505
Scripps Cancer Center
La Jolla, California, United States, 92037
UCSD - Moore's Cancer Center
La Jolla, California, United States, 92093
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
University of California Medical Center
Orange, California, United States, 92868
Saint Helena Hospital
Saint Helena, California, United States, 94574
Pacific Hematology Oncology Associates
San Francisco, California, United States, 94115
The Oncology Institute of Hope and Innovation
Whittier, California, United States, 90603
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
United States, Connecticut
Stamford Hospital
Stamford, Connecticut, United States, 06902
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Florida
University of Miami, Sylvester comprehensive Cancer Center
Miami, Florida, United States, 33136
H. Lee Moffit Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30318
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Kentucky
Norton Cancer Institute - Norton HealthCare Pavilion
Louisville, Kentucky, United States, 40202
United States, Maryland
Johns Hopkins University Hospital
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Lahey Clinic
Burlington, Massachusetts, United States, 01805
University of Mass Medical School
Worcester, Massachusetts, United States, 01655
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States, 55407
Unniversity of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Research Medical Center
Kansas City, Missouri, United States, 64132
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
United States, New Jersey
St. Joseph's Regional Medical Center
Paterson, New Jersey, United States, 07503
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
North Shore Long Island Jewish Health System
Lake Success, New York, United States, 11042
Mount Sinai Medical Center
New York, New York, United States, 10029
Columbia University Medical Center
New York, New York, United States, 10032
University of Rochester
Rochester, New York, United States, 14642
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
United States, Oklahoma
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
UPMC Cancer Center
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Greenville Health System
Greenville, South Carolina, United States, 29605
United States, Texas
Texas Oncology - Baylor
Dallas, Texas, United States, 75246
Cancer Care Centers of South Texas
New Braunfels, Texas, United States, 78130
Texas Oncology
Tyler, Texas, United States, 75702
United States, Washington
Columbia Basin Hematology and Oncology
Kennewick, Washington, United States, 99336
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
NorthWest Medical Specialties, PLLC
Tacoma, Washington, United States, 98405
United States, Wisconsin
University of Wisconsin Hospitals and Clinics
Madison, Wisconsin, United States, 53792
Froedtert Hospital, Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Halozyme Therapeutics
Study Director: Dimitrios Chondros, MD Halozyme Therapeutics

Responsible Party: Halozyme Therapeutics Identifier: NCT01839487     History of Changes
Other Study ID Numbers: HALO-109-202
First Posted: April 25, 2013    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: January 2018

Keywords provided by Halozyme Therapeutics:
pancreatic ductal carcinoma(PDA)
Pancreatic ductal carcinoma

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs