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COMPLETED Phase 2

PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation

NCT01402063 · View on ClinicalTrials.gov ↗

Study Summary

To obtain preliminary data in a randomized phase II study whether PPX/RT improves progression-free survival as compared to temozolomide/RT for patients with GBM without MGMT methylation.

Conditions Studied

Interventions

  • DRUG Temozolomide
  • DRUG PPX (CT2103)

Study Locations (9)

Pennsylvania

  • PSU — Hershey
  • Thomas Jefferson University Cancer Center — Philadelphia

California

  • UCSD Cancer Center — La Jolla

Maine

  • Maine Medical Center — Scarborough

Massachusetts

  • UMASS Medical Center Cancer Center — Worcester

New York

  • SUNY Medical Center — Syracuse

Rhode Island

  • Rhode Island Hospital — Providence

Texas

  • UT Southwestern Cancer Center — Dallas

Washington

  • University of Washington — Seattle

Trial Details

FieldValue
Enrollment Target 63 participants
Start Date 2011-09
Est. Completion 2015-06
Phase Phase 2

Sponsor

Brown University

268 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01402063

The ClinicalTrials.gov registry entry for NCT01402063 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 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brown University, which has 268 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 Glioblastoma Multiforme appearing as the primary indexed condition, and to 2 interventions — of which Temozolomide 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: NCT01402063 reports 9 study locations spanning 8 distinct geographic areas — top geographies include Pennsylvania, California, Maine. 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 NCT01402063 about?

NCT01402063 is a clinical study titled "PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation". To obtain preliminary data in a randomized phase II study whether PPX/RT improves progression-free survival as compared to temozolomide/RT for patients with GBM without MGMT methylation.

What is the current status of trial NCT01402063?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2011-09. Estimated completion is 2015-06.

What conditions does trial NCT01402063 study?

This clinical trial studies the following conditions: Glioblastoma Multiforme. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01402063?

The interventions under investigation include: Temozolomide (DRUG), PPX (CT2103) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01402063?

This trial is sponsored by Brown University, which has 268 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01402063 being conducted?

This trial has 9 study locations across California, Maine, Massachusetts, New York, Pennsylvania. 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