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NCT01839487 · ClinicalTrials.gov registry record · Phase 2
PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Participants With Stage IV Untreated Pancreatic Cancer
A Phase 2 study of Metastatic Pancreatic Cancer, sponsored by Halozyme Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 279
- Enrollment target
- 20
- Study locations
NCT01839487 is a Phase 2 study of Metastatic Pancreatic Cancer that has completed, run by Halozyme Therapeutics. The registered enrollment target is 279 participants, above the 98-participant average among 32 other Metastatic Pancreatic Cancer trials with a reported enrollment target (185% higher). The trial reports 20 study locations across 8 states.
The verdict
NCT01839487, a Phase 2 study of Metastatic Pancreatic Cancer, has completed, sponsored by Halozyme Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 279 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 279 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 98-participant average among 32 other Metastatic Pancreatic Cancer trials with a reported enrollment target (185% higher). The listed sponsor is Halozyme Therapeutics, which has 31 total studies on file at ClinicalTrials.gov.
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.
NCT01839487 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Arizona, Alabama.
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.
What interventions are being tested in trial NCT01839487?
The interventions under investigation include: Dexamethasone (DRUG), Gemcitabine (DRUG), Nab-paclitaxel (DRUG), Enoxaparin (DRUG), PEGPH20 (DRUG).
Who is sponsoring clinical trial NCT01839487?
This trial is sponsored by Halozyme Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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