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NCT05768919 · ClinicalTrials.gov registry record · Phase 1
Study of Liposomal Curcumin in Combination With RT and TMZ in Patients With Newly Diagnosed High-Grade Gliomas
A Phase 1 study of Glioblastoma, sponsored by SignPath Pharma.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT05768919: Recruiting Phase 1 study of Glioblastoma, sponsored by SignPath Pharma.
NCT05768919 is a Phase 1 study of Glioblastoma that is actively recruiting participants, run by SignPath Pharma. The registered enrollment target is 30 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (72% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05768919, a Phase 1 study of Glioblastoma, is actively recruiting participants, sponsored by SignPath Pharma.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
Study Summary
The objective of this study is to assess the tolerability, safety, and efficacy of Liposomal Curcumin (LC) in combination with radiotherapy (RT) and Temozolomide (TMZ) in patients with newly diagnosed High-Grade Gliomas (HGG).
Primary Outcome
The MTD/RP2D of LC in combination with XRT and TMZ and adjuvant TMZ in newly diagnosed HGG will be determined by recording the number of observed dose limiting toxicities (DLTs). DLTs, as defined in this study occur if in the first three patients entered at a dose-level, more than one of these 3 experiences a serious adverse event, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5. If one of the first three patients entered at the le
Conditions Studied
Interventions
- DRUG Treatment Period 1
- DRUG Treatment Period 2
- DRUG Treatment Period 3
- DRUG Treatment Period 4a
Study Locations (2)
District of Columbia
- Sibley Memorial Hospital - Washington D.C.
Maryland
- Johns Hopkins University/Johns Hopkins Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-03-03 |
| Est. Completion | 2027-05 |
| Phase | Phase 1 |
What NCT05768919 shows while recruiting
NCT05768919 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Glioblastoma appearing as the primary indexed condition, and to 4 interventions - of which Treatment Period 1 is the first listed.
NCT05768919 reports a single indexed study location in District of Columbia, Maryland.
Frequently Asked Questions
What is clinical trial NCT05768919 about?
NCT05768919 is a clinical study titled "Study of Liposomal Curcumin in Combination With RT and TMZ in Patients With Newly Diagnosed High-Grade Gliomas". The objective of this study is to assess the tolerability, safety, and efficacy of Liposomal Curcumin (LC) in combination with radiotherapy (RT) and Temozolomide (TMZ) in patients with newly diagnosed High-Grade Gliomas (HGG).
What is the current status of trial NCT05768919?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2023-03-03. Estimated completion is 2027-05.
What conditions does trial NCT05768919 study?
This clinical trial studies the following conditions: Glioblastoma.
What interventions are being tested in trial NCT05768919?
The interventions under investigation include: Treatment Period 1 (DRUG), Treatment Period 2 (DRUG), Treatment Period 3 (DRUG), Treatment Period 4a (DRUG).
Who is sponsoring clinical trial NCT05768919?
This trial is sponsored by SignPath Pharma, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05768919 being conducted?
This trial has 2 study locations across District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05768919's enrollment target sits among peer trials
30 124th of 199 higher than 69 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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