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COMPLETED Phase 1

Study of Gemcitabine + PEGPH20 vs Gemcitabine Alone in Stage IV Previously Untreated Pancreatic Cancer

NCT01453153 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 28 participants
Start Date 2011-09
Est. Completion 2015-05
Phase Phase 1

Sponsor

Halozyme Therapeutics

13 total trials

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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. It is categorized as Phase 1, 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 28 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 Stage IV Pancreatic Cancer appearing as the primary indexed condition, and to 3 interventions — of which Placebo 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: NCT01453153 reports 12 study locations spanning 7 distinct geographic areas — top geographies include Other, New York, Arkansas. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01453153?

The interventions under investigation include: Placebo (DRUG), Gemcitabine (DRUG), PEGPH20 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01453153?

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 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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial