PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Subjects With Stage IV Untreated Pancreatic Cancer (HALO-109-202)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Halozyme Therapeutics
ClinicalTrials.gov Identifier:
NCT01839487
First received: April 22, 2013
Last updated: April 21, 2014
Last verified: January 2014
  Purpose

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. Phase 2 (safety and treatment effect), 124 subjects, 1:1 ratio, PAG:AG, preceded by 8 subject Run-In phase (safety and tolerability).


Condition Intervention Phase
Metastatic Pancreatic Cancer
Drug: PEGPH20+nab-paclitaxel+gemcitabine
Drug: nab-paclitaxel + gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Halozyme Therapeutics:

Primary Outcome Measures:
  • Estimate the PFS duration of PEGPH20 combined with NAB plus GEM [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Estimate relative benefit of PAG treatment vs. AG treatment, as assessed by the PFS ratio [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • To evaluate the safety and tolerability profile of PAG and AG treatment groups [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • To characterize the plasma PK of PEGPH20 when given in combination with NAB + GEM [ Time Frame: Various visits and timepoints ] [ Designated as safety issue: No ]

Estimated Enrollment: 132
Study Start Date: April 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEGPH20
PEGPH20+nab-paclitaxel+Gemcitabine
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

Detailed Description:
  1. Phase 2, multicenter open-label randomized study with a run-in phase. Run-in phase to evaluate safety and tolerability of PEGPH20 + Nab-paclitaxel + Gemcitabine vs. Nab-paclitaxel + Gemcitabine. 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, 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ).
  • 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 bilirubin,aspartate transaminase(AST), alanine transaminase(ALT), serum creatinine and albumin, absolute neutrophil count (ANC), hemoglobin, hematocrit and partial thromboplastin time(PTT) within specified values/criteria per protocol prior to dosing.

Key Exclusion Criteria:

  • Non metastatic pancreatic ductal adenocarcinoma
  • Known Central nervous system involvement, brain metastasis
  • New York(NY) Heart Assoc Class III or IV cardiac disease or Myocardial infarction within the past 12 months.
  • Active, uncontrolled bacterial, viral or fungal infection requiring systemic therapy.
  • 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 or curatively-treated cervical cancer in-situ.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01839487

  Hide Study Locations
Locations
United States, Alabama
Alabama Oncology
Birmingham, Alabama, United States, 35213
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
UCSD - Moore's Cancer Center
La Jolla, California, United States, 92093
Scripps Cancer Center
La Jolla, California, United States, 92037
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
University of California Medical Center
Orange, California, United States, 92868
Pacific Hematology Oncology Associates
San Francisco, California, United States, 94115
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, 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
University of Chicago
Chicago, Illinois, United States, 60637
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
Tufts Medical Center
Boston, Massachusetts, United States, 02111
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
Washington University School of Medicine
St 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
Columbia University Medical Center
New York, New York, United States, 10032
Mount Sinai Medical Center
New York, New York, United States, 10029
University of Rochester
Rochester, New York, United States, 14642
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, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
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, Virginia
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
United States, Washington
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
Investigators
Study Director: Joy Zhu, MD, Ph.D Halozyme Therapeutics
  More Information

No publications provided

Responsible Party: Halozyme Therapeutics
ClinicalTrials.gov Identifier: NCT01839487     History of Changes
Other Study ID Numbers: HALO-109-202
Study First Received: April 22, 2013
Last Updated: April 21, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 22, 2014