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NCT01906385 · ClinicalTrials.gov registry record · Phase 1
Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)
A Phase 1 study of Glioma, sponsored by Plus Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
- 3
- Study locations
NCT01906385 is a Phase 1 study of Glioma that is actively recruiting participants, run by Plus Therapeutics. The registered enrollment target is 55 participants, below the 209-participant average among 87 other Glioma trials with a reported enrollment target (74% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT01906385, a Phase 1 study of Glioma, is actively recruiting participants, sponsored by Plus Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a multi-center, sequential cohort, open-label, volume and dose escalation study of the safety, tolerability, and distribution of 186RNL given by convection enhanced delivery to patients with recurrent or progressive malignant glioma after standard surgical, radiation, and/or chemotherapy treatment. The study uses a modified Fibonacci dose escalation, followed by an expansion at the maximum tolerated dose (MTD) to determine efficacy. The starting absorbed dose is 1mCi in a volume of 0.660mL.
Conditions Studied
Interventions
- DRUG Rhenium Liposome Treatment
Study Locations (3)
Texas
- UT Southwestern Medical Center - Dallas
- The Cancer Therapy and Research Center at UTHSCSA - San Antonio
New York
- Northshore University Hospital - Manhasset
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2015-06-03 |
| Est. Completion | 2025-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01906385
The ClinicalTrials.gov registry entry for NCT01906385 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 209-participant average among 87 other Glioma trials with a reported enrollment target (74% lower). The listed sponsor is Plus Therapeutics, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Glioma appearing as the primary indexed condition, and to 1 intervention - of which Rhenium Liposome Treatment is the first listed.
NCT01906385 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Texas, New York.
Frequently Asked Questions
What is clinical trial NCT01906385 about?
NCT01906385 is a clinical study titled "Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)". This is a multi-center, sequential cohort, open-label, volume and dose escalation study of the safety, tolerability, and distribution of 186RNL given by convection enhanced delivery to patients with recurrent or progressive malignant glioma after standard surgical, radiation, and/or chemotherapy tre...
What is the current status of trial NCT01906385?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2015-06-03. Estimated completion is 2025-12.
What conditions does trial NCT01906385 study?
This clinical trial studies the following conditions: Glioma.
What interventions are being tested in trial NCT01906385?
The interventions under investigation include: Rhenium Liposome Treatment (DRUG).
Who is sponsoring clinical trial NCT01906385?
This trial is sponsored by Plus Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01906385 being conducted?
This trial has 3 study locations across New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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