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NCT01453153 · ClinicalTrials.gov registry record · Phase 1
Study of Gemcitabine + PEGPH20 vs Gemcitabine Alone in Stage IV Previously Untreated Pancreatic Cancer
A Phase 1 study of Stage IV Pancreatic Cancer, sponsored by Halozyme Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 12
- Study locations
NCT01453153 is a Phase 1 study of Stage IV Pancreatic Cancer that has completed, run by Halozyme Therapeutics. The registered enrollment target is 28 participants, below the 77-participant average among 15 other Stage IV Pancreatic Cancer trials with a reported enrollment target (64% lower). The trial reports 12 study locations across 7 states.
The verdict
NCT01453153, a Phase 1 study of Stage IV Pancreatic Cancer, has completed, sponsored by Halozyme Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 12
- Study locations
Study Summary
Phase 1B: Open label (all patients receive PEGPH20+gemcitabine), dose escalation, safety and tolerability study to determine the safe dose of PEGPH20 to use in combination with gemcitabine in Stage IV previously untreated pancreatic cancer patients. Phase 2: Randomized, double blind study to compare the effect of overall survival of gemcitabine plus PEGPH20 vs gemcitabine plus placebo in Stage IV previously untreated pancreatic cancer patients.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Gemcitabine
- DRUG PEGPH20
Study Locations (12)
Other
- Chelyabinsk Regional Clinical Oncology Center - Chelyabinsk
- Russian Oncological Research Center n.a. N.N. Blokhin - Moscow
- Medical Radiological Research Center - Obninsk
- Omsk Regional Budget Medical Institution - Omsk
New York
- NSLIJ Health System, Monter Cancer Center - New Hyde Park
- Mount Sinai School of Medicine - New York
- SUNY Upstate Medical University - Syracuse
Arkansas
- Highlands Oncology Group - Fayetteville
California
- California Pacific Medical Center - San Francisco
Indiana
- Indiana University Melvin and Bren Simon Cancer Center - Indianapolis
New Jersey
- UMDNJ - New Jersey Medical School - Newark
Washington
- Seattle Cancer Care Alliance - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2011-09 |
| Est. Completion | 2015-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01453153
The ClinicalTrials.gov registry entry for NCT01453153 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 77-participant average among 15 other Stage IV Pancreatic Cancer trials with a reported enrollment target (64% lower). The listed sponsor is Halozyme Therapeutics, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Stage IV Pancreatic Cancer appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01453153 reports 12 study locations spanning 7 distinct geographic areas - top geographies include Other, New York, Arkansas.
Frequently Asked Questions
What is clinical trial NCT01453153 about?
NCT01453153 is a clinical study titled "Study of Gemcitabine + PEGPH20 vs Gemcitabine Alone in Stage IV Previously Untreated Pancreatic Cancer". Phase 1B: Open label (all patients receive PEGPH20+gemcitabine), dose escalation, safety and tolerability study to determine the safe dose of PEGPH20 to use in combination with gemcitabine in Stage IV previously untreated pancreatic cancer patients. Phase 2: Randomized, double blind study to compar...
What is the current status of trial NCT01453153?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2011-09. Estimated completion is 2015-05.
What conditions does trial NCT01453153 study?
This clinical trial studies the following conditions: Stage IV Pancreatic Cancer.
What interventions are being tested in trial NCT01453153?
The interventions under investigation include: Placebo (DRUG), Gemcitabine (DRUG), PEGPH20 (DRUG).
Who is sponsoring clinical trial NCT01453153?
This trial is sponsored by Halozyme Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01453153 being conducted?
This trial has 12 study locations across Arkansas, California, Indiana, New Jersey, New York. 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
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.