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NCT01790503 · ClinicalTrials.gov registry record · Phase 1
A Phase 1b/2 Study of PLX3397 + Radiation Therapy + Temozolomide in Patients With Newly Diagnosed Glioblastoma
A Phase 1 study of Patients With Newly Diagnosed Glioblastoma, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
- 9
- Study locations
NCT01790503: Completed Phase 1 study of Patients With Newly Diagnosed Glioblastoma, sponsored by Daiichi Sankyo.
NCT01790503 is a Phase 1 study of Patients With Newly Diagnosed Glioblastoma that has completed, run by Daiichi Sankyo. The registered enrollment target is 65 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01790503, a Phase 1 study of Patients With Newly Diagnosed Glioblastoma, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
- 9
- Study locations
Study Summary
The study objectives are to assess the potential for PLX3397 to improve the efficacy of standard of care radiation therapy (RT) + temozolomide in patients with newly diagnosed glioblastoma (GBM).
Primary Outcome
Progression was determined by Response Assessment in Neuro-Oncology (RANO) criteria and progression-free survival (PFS) was analyzed based on the non-parametric Kaplan-Meier method.
Conditions Studied
Interventions
- RADIATION Radiation Therapy
- DRUG Temozolomide
- DRUG PLX3397
Study Locations (9)
Massachusetts
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
- Dana Farber Cancer Institute - Boston
Illinois
- Northwestern Memorial Hospital - Chicago
Michigan
- Henry Ford Hospital - Detroit
New York
- Columbia University Medical Center - New York
Ohio
- James Cancer Hospital/Ohio State University - Columbia
Utah
- Huntsman Cancer Institute University of Utah - Salt Lake City
Washington
- Seattle Cancer Care Alliance - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2013-07-18 |
| Est. Completion | 2020-03-04 |
| Phase | Phase 1 |
What the finished NCT01790503 record still lists
NCT01790503 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 1 condition, with Patients With Newly Diagnosed Glioblastoma appearing as the primary indexed condition, and to 3 interventions - of which Radiation Therapy is the first listed.
NCT01790503 lists 9 locations in 7 states (Massachusetts, Illinois, Michigan).
Frequently Asked Questions
What is clinical trial NCT01790503 about?
NCT01790503 is a clinical study titled "A Phase 1b/2 Study of PLX3397 + Radiation Therapy + Temozolomide in Patients With Newly Diagnosed Glioblastoma". The study objectives are to assess the potential for PLX3397 to improve the efficacy of standard of care radiation therapy (RT) + temozolomide in patients with newly diagnosed glioblastoma (GBM).
What is the current status of trial NCT01790503?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2013-07-18. Estimated completion is 2020-03-04.
What conditions does trial NCT01790503 study?
This clinical trial studies the following conditions: Patients With Newly Diagnosed Glioblastoma.
What interventions are being tested in trial NCT01790503?
The interventions under investigation include: Radiation Therapy (RADIATION), Temozolomide (DRUG), PLX3397 (DRUG).
Who is sponsoring clinical trial NCT01790503?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01790503 being conducted?
This trial has 9 study locations across Illinois, Massachusetts, Michigan, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01790503's enrollment target sits among peer trials
65 798th of 2000 higher than 1,193 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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