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NCT05109728 · ClinicalTrials.gov registry record · Phase 1
A Dose Finding Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination With Standard of Care and in Recurrent Glioblastoma as a Single Agent.
A Phase 1 study of Glioblastoma, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
- 14
- Study locations
NCT05109728: Active Phase 1 study of Glioblastoma, sponsored by Novartis Pharmaceuticals.
NCT05109728 is a Phase 1 study of Glioblastoma that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 65 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (40% lower). The trial reports 14 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05109728, a Phase 1 study of Glioblastoma, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
- 14
- Study locations
Study Summary
A Dose Finding Study of \[177Lu\]Lu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination with Standard of Care and in Recurrent Glioblastoma as a Single Agent
Primary Outcome
A dose-limiting toxicity (DLT) is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that meets any of the criteria defining dose-limiting toxicities and with an onset during the DLT observation period specified for the group. • Group 1: DLT observation period of 49 to 52 days starting from the first administration of \[177Lu\]Lu-DOTA-TATE (Day 1) and ending with the completion of concomitant RT
Conditions Studied
Interventions
- DRUG [177Lu]Lu-DOTA-TATE
- DRUG [68Ga]Ga-DOTA-TATE
- OTHER Temozolomide
- OTHER Radiotherapy
Study Locations (14)
Other
- Novartis Investigative Site - Bron
- Novartis Investigative Site - Marseille
- Novartis Investigative Site - Porto
- Novartis Investigative Site - Barcelona
- Novartis Investigative Site - Barcelona
- Novartis Investigative Site - Madrid
- Novartis Investigative Site - Madrid
- Novartis Investigative Site - Lausanne
- Novartis Investigative Site - Zurich
New York
- Col Uni Med Center New York Presby - New York
Pennsylvania
- University of Pittsburgh - Pittsburgh
Texas
- MD Anderson Cancer Center Uni of Te - Houston
Wisconsin
- University of Wisconsin School of Medicine and Public Health - Madison
Andalusia
- Novartis Investigative Site - Granada
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2022-05-10 |
| Est. Completion | 2027-07-31 |
| Phase | Phase 1 |
What the registry record for NCT05109728 still lists
NCT05109728 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Glioblastoma appearing as the primary indexed condition, and to 4 interventions - of which [177Lu]Lu-DOTA-TATE is the first listed.
NCT05109728 lists 14 locations in 6 states (Other, New York, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT05109728 about?
NCT05109728 is a clinical study titled "A Dose Finding Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination With Standard of Care and in Recurrent Glioblastoma as a Single Agent.". A Dose Finding Study of \[177Lu\]Lu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination with Standard of Care and in Recurrent Glioblastoma as a Single Agent
What is the current status of trial NCT05109728?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2022-05-10. Estimated completion is 2027-07-31.
What conditions does trial NCT05109728 study?
This clinical trial studies the following conditions: Glioblastoma.
What interventions are being tested in trial NCT05109728?
The interventions under investigation include: [177Lu]Lu-DOTA-TATE (DRUG), [68Ga]Ga-DOTA-TATE (DRUG), Temozolomide (OTHER), Radiotherapy (OTHER).
Who is sponsoring clinical trial NCT05109728?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05109728 being conducted?
This trial has 14 study locations across New York, Pennsylvania, Texas, Wisconsin, Andalusia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05109728's enrollment target sits among peer trials
65 69th of 199 higher than 131 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma 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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