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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: Completed Phase 1 study of Stage IV Pancreatic Cancer, sponsored by Halozyme Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The safety and tolerability profile of PEGPH20 used in combination with gemcitabine was assessed by measuring the number of participants with a DLT during the dose-escalation phase of the study. A DLT was defined as any treatment-emergent National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE), Version 4.0, Grade 3 or greater event occurring within the first 4 weeks of treatment that was considered related to PEGPH20. Any PEGPH20 treatment-related AE that resulted i
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 |
What the finished NCT01453153 record still lists
NCT01453153 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 77-participant average among 15 other Stage IV Pancreatic Cancer trials with a reported enrollment target (64% lower).
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 lists 12 locations in 7 states (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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01453153's enrollment target sits among peer trials
28 8th of 15 higher than 8 of 15 other Stage IV Pancreatic Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Pancreatic Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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