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PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Participants With Stage IV Untreated Pancreatic Cancer
NCT01839487 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Gemcitabine
- DRUG Nab-paclitaxel
- DRUG Enoxaparin
- DRUG PEGPH20
Study Locations (20)
California
- Providence St Joseph Medical Center — Burbank
- Scripps Cancer Center — La Jolla
- UCSD - Moore's Cancer Center — La Jolla
- Cedars-Sinai Medical Center — Los Angeles
- University of California Medical Center — Orange
- Pacific Hematology Oncology Associates — San Francisco
- Saint Helena Hospital — St. Helena
- The Oncology Institute of Hope and Innovation — Whittier
Arizona
- Banner MD Anderson Cancer Center — Gilbert
- Mayo Clinic - Scottsdale — Scottsdale
- Arizona Oncology Associates, PC — Tucson
Alabama
- Alabama Oncology — Birmingham
- University of South Alabama Mitchell Cancer Institute — Mobile
Colorado
- University of Colorado Cancer Center — Aurora
- Rocky Mountain Cancer Center — Denver
Florida
- University of Miami, Sylvester comprehensive Cancer Center — Miami
- H. Lee Moffit Cancer Center — Tampa
Arkansas
- Highlands Oncology Group — Fayetteville
Connecticut
- Stamford Hospital — Stamford
District of Columbia
- Georgetown University Medical Center — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 279 participants |
| Start Date | 2013-05-14 |
| Est. Completion | 2018-09-26 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01839487
The ClinicalTrials.gov registry entry for NCT01839487 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 279 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Halozyme Therapeutics, which has 13 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Metastatic Pancreatic Cancer appearing as the primary indexed condition, and to 5 interventions — of which Dexamethasone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01839487 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Arizona, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01839487 about?
NCT01839487 is a clinical study titled "PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Participants With Stage IV Untreated Pancreatic Cancer". 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 formu...
What is the current status of trial NCT01839487?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 279 participants. The study started on 2013-05-14. Estimated completion is 2018-09-26.
What conditions does trial NCT01839487 study?
This clinical trial studies the following conditions: Metastatic Pancreatic Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01839487?
The interventions under investigation include: Dexamethasone (DRUG), Gemcitabine (DRUG), Nab-paclitaxel (DRUG), Enoxaparin (DRUG), PEGPH20 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01839487?
This trial is sponsored by Halozyme Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01839487 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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