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NCT07144254 · ClinicalTrials.gov registry record · Phase 1
Tegavivint With Gemcitabine in Patients With Relapsed or Refractory Osteosarcoma
A Phase 1 study of Refractory Osteosarcoma and Osteosarcoma Recurrent, sponsored by Emory University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT07144254: Recruiting Phase 1 study of Refractory Osteosarcoma and Osteosarcoma Recurrent, sponsored by Emory University.
NCT07144254 is a Phase 1 study of Refractory Osteosarcoma and Osteosarcoma Recurrent that is actively recruiting participants, run by Emory University. The registered enrollment target is 24 participants, below the 34-participant average among 7 other Refractory Osteosarcoma trials with a reported enrollment target (29% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07144254, a Phase 1 study of Refractory Osteosarcoma and Osteosarcoma Recurrent, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to define the maximum tolerated dose (MTD) and/or Recommended phase 2 dose (RP2D) of Tegavivint in combination with Gemcitabine in patients with relapsed or refractory osteosarcoma (OS). The study will also investigate the toxicities of Tegavivint in combination with gemcitabine in patients with relapsed or refractory OS.
Primary Outcome
The maximum tolerated dose (MTD) of Tegavivint administered intravenously over 4 hours on days 1, 8, and 15 at the dose level assigned at study entry in combination with gemcitabine. The MTD is empirically defined as the highest dose level at which no more than one patient is experiencing a dose-limiting toxicity (DLT) and the next higher dose level has been determined to be too toxic. The MTD will be determined during Cycle 1 (each cycle is 21 days)
Conditions Studied
Interventions
- DRUG Gemcitabine
- DRUG Tegavivint
Study Locations (1)
Georgia
- Arthur M. Blank Children's Healthcare of Atlanta - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2026-01-22 |
| Est. Completion | 2028-05 |
| Phase | Phase 1 |
What NCT07144254 shows while recruiting
NCT07144254 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 34-participant average among 7 other Refractory Osteosarcoma trials with a reported enrollment target (29% lower).
The record links to 4 conditions, with Refractory Osteosarcoma appearing as the primary indexed condition, and to 2 interventions - of which Gemcitabine is the first listed.
NCT07144254 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT07144254 about?
NCT07144254 is a clinical study titled "Tegavivint With Gemcitabine in Patients With Relapsed or Refractory Osteosarcoma". The goal of this clinical trial is to define the maximum tolerated dose (MTD) and/or Recommended phase 2 dose (RP2D) of Tegavivint in combination with Gemcitabine in patients with relapsed or refractory osteosarcoma (OS). The study will also investigate the toxicities of Tegavivint in combination w...
What is the current status of trial NCT07144254?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2026-01-22. Estimated completion is 2028-05.
What conditions does trial NCT07144254 study?
This clinical trial studies the following conditions: Refractory Osteosarcoma, Osteosarcoma Recurrent, Osteosarcoma in Children, Relapsed Osteosarcoma.
What interventions are being tested in trial NCT07144254?
The interventions under investigation include: Gemcitabine (DRUG), Tegavivint (DRUG).
Who is sponsoring clinical trial NCT07144254?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07144254 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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