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NCT07125183 · ClinicalTrials.gov registry record · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
A Phase 2 study of Sarcoma, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT07125183: Recruiting Phase 2 study of Sarcoma, sponsored by University of Colorado, Denver.
NCT07125183 is a Phase 2 study of Sarcoma that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 20 participants, below the 921-participant average among 122 other Sarcoma trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07125183, a Phase 2 study of Sarcoma, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The overall goal of this Phase 2 study is to determine the efficacy of a lower dose weekly schedule of doxorubicin in patients with unresectable leiomyosarcomas aged 65-100 years old. While doxorubicin is the standard of care therapy for sarcomas not removable by surgery, older or more frail patients may struggle to tolerate side effects of the treatment including immune cell suppression. Previous studies have suggested that similar anti-tumor activity can be obtained using a lower dose, weekly administration schedule of doxorubicin. In this study, the investigators will determine progression-free survival rate at 12 weeks, with secondary endpoints including quality of life and adverse events in this population. Importantly, doxorubicin can also induce immune stimulatory effects when administered at lower doses, based on animal data. Thus, correlative samples including blood and tumor biopsies will also explore the effects of immune cells and foreignness of the tumor prior to and during treatment in study patients.
Primary Outcome
weekly doxorubicin chemotherapy in anthracycline-naïve patients measured through PFS at 12 weeks by RECIST 1.1
Conditions Studied
Interventions
- DRUG Doxorubicin
Study Locations (1)
Colorado
- University Of Colorado Hospital - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-12 |
| Est. Completion | 2029-12 |
| Phase | Phase 2 |
What NCT07125183 shows while recruiting
NCT07125183 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 921-participant average among 122 other Sarcoma trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Sarcoma appearing as the primary indexed condition, and to 1 intervention - of which Doxorubicin is the first listed.
NCT07125183 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT07125183 about?
NCT07125183 is a clinical study titled "Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma". The overall goal of this Phase 2 study is to determine the efficacy of a lower dose weekly schedule of doxorubicin in patients with unresectable leiomyosarcomas aged 65-100 years old. While doxorubicin is the standard of care therapy for sarcomas not removable by surgery, older or more frail patient...
What is the current status of trial NCT07125183?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2026-12. Estimated completion is 2029-12.
What conditions does trial NCT07125183 study?
This clinical trial studies the following conditions: Sarcoma.
What interventions are being tested in trial NCT07125183?
The interventions under investigation include: Doxorubicin (DRUG).
Who is sponsoring clinical trial NCT07125183?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07125183 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sarcoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07125183's enrollment target sits among peer trials
20 101st of 122 higher than 19 of 122 other Sarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sarcoma 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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