PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Participants With Stage IV Untreated Pancreatic Cancer
Public ClinicalTrials.gov record NCT01839487. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is designed to compare the treatment effect of PEGPH20 combined with nab-paclitaxel (NAB) and gemcitabine (GEM) \[PAG\] to NAB and GEM \[AG\] in participants with Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA). 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.
Study identification
- NCT ID
- NCT01839487
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 279 participants
Conditions and interventions
Conditions
Interventions
- PEGPH20 Drug
- Nab-paclitaxel Drug
- Gemcitabine Drug
- Dexamethasone Drug
- Enoxaparin Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 14, 2013 (Actual)
- Primary completion
- May 1, 2018 (Actual)
- Completion
- Sep 26, 2018 (Actual)
- Last update posted
- Jul 20, 2020
2013 – 2018
United States locations
- U.S. sites
- 51
- U.S. states
- 26
- U.S. cities
- 48
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Oncology | Birmingham | Alabama | 35213 | — |
| University of South Alabama Mitchell Cancer Institute | Mobile | Alabama | 36604 | — |
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | — |
| Mayo Clinic - Scottsdale | Scottsdale | Arizona | 85259 | — |
| Arizona Oncology Associates, PC | Tucson | Arizona | 85704 | — |
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | — |
| Providence St Joseph Medical Center | Burbank | California | 91505 | — |
| Scripps Cancer Center | La Jolla | California | 92037 | — |
| UCSD - Moore's Cancer Center | La Jolla | California | 92093 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| University of California Medical Center | Orange | California | 92868 | — |
| Pacific Hematology Oncology Associates | San Francisco | California | 94115 | — |
| Saint Helena Hospital | St. Helena | California | 94574 | — |
| The Oncology Institute of Hope and Innovation | Whittier | California | 90603 | — |
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | — |
| Rocky Mountain Cancer Center | Denver | Colorado | 80218 | — |
| Stamford Hospital | Stamford | Connecticut | 06902 | — |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | — |
| University of Miami, Sylvester comprehensive Cancer Center | Miami | Florida | 33136 | — |
| H. Lee Moffit Cancer Center | Tampa | Florida | 33612 | — |
| Piedmont Hospital | Atlanta | Georgia | 30318 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Norton Cancer Institute - Norton HealthCare Pavilion | Louisville | Kentucky | 40202 | — |
| Johns Hopkins University Hospital | Baltimore | Maryland | 21231 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Lahey Clinic | Burlington | Massachusetts | 01805 | — |
| University of Mass Medical School | Worcester | Massachusetts | 01655 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Virginia Piper Cancer Institute | Minneapolis | Minnesota | 55407 | — |
| Unniversity of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Research Medical Center | Kansas City | Missouri | 64132 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | — |
| St. Joseph's Regional Medical Center | Paterson | New Jersey | 07503 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| North Shore Long Island Jewish Health System | Lake Success | New York | 11042 | — |
| Mount Sinai Medical Center | New York | New York | 10029 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Gabrail Cancer Center | Canton | Ohio | 44718 | — |
| University of Oklahoma Health Science Center | Oklahoma City | Oklahoma | 73104 | — |
| UPMC Cancer Center | Pittsburgh | Pennsylvania | 15213 | — |
| Greenville Health System | Greenville | South Carolina | 29605 | — |
| Texas Oncology - Baylor | Dallas | Texas | 75246 | — |
| Cancer Care Centers of South Texas | New Braunfels | Texas | 78130 | — |
| Texas Oncology | Tyler | Texas | 75702 | — |
| Columbia Basin Hematology and Oncology | Kennewick | Washington | 99336 | — |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | — |
| NorthWest Medical Specialties, PLLC | Tacoma | Washington | 98405 | — |
| University of Wisconsin Hospitals and Clinics | Madison | Wisconsin | 53792 | — |
| Froedtert Hospital, Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01839487, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 20, 2020 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01839487 live on ClinicalTrials.gov.