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Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma
NCT05711615 · View on ClinicalTrials.gov ↗
Study Summary
This phase I trial tests the safety, side effects, and best dose of combination therapy with liposomal doxorubicin and peposertib in treating patients with sarcoma that has spread from where it first started, to other places in the body (metastatic), or cannot be removed by surgery (unresectable) and for which no known cure is available (advanced). Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Liposomal doxorubicin is a form of the anticancer drug doxorubicin that is contained inside very tiny, fat-like particles. Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug. Peposertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also enhance the activity of chemo- and radiotherapy. There is some pre-clinical evidence in animal models that combining peposertib with liposomal doxorubicin can shrink or stabilize certain types of cancer for longer than either drug alone, but it is not known if this will happen in people. Combination therapy with liposomal doxorubicin and peposertib may be effective in treating patients with advanced sarcoma.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Biopsy Procedure
- PROCEDURE Echocardiography Test
Study Locations (16)
Illinois
- University of Chicago Comprehensive Cancer Center — Chicago
- UC Comprehensive Cancer Center at Silver Cross — New Lenox
- University of Chicago Medicine-Orland Park — Orland Park
California
- Los Angeles General Medical Center — Los Angeles
- USC / Norris Comprehensive Cancer Center — Los Angeles
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore
- National Cancer Institute Developmental Therapeutics Clinic — Bethesda
Missouri
- Washington University School of Medicine — St Louis
- Siteman Cancer Center-South County — St Louis
Colorado
- UCHealth University of Colorado Hospital — Aurora
Florida
- University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami
Massachusetts
- Dana-Farber Cancer Institute — Boston
Michigan
- University of Michigan Rogel Cancer Center — Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-02-06 |
| Est. Completion | 2026-05-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05711615
The ClinicalTrials.gov registry entry for NCT05711615 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Metastatic Sarcoma appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05711615 reports 16 study locations spanning 11 distinct geographic areas — top geographies include Illinois, California, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05711615 about?
NCT05711615 is a clinical study titled "Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma". This phase I trial tests the safety, side effects, and best dose of combination therapy with liposomal doxorubicin and peposertib in treating patients with sarcoma that has spread from where it first started, to other places in the body (metastatic), or cannot be removed by surgery (unresectable) an...
What is the current status of trial NCT05711615?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2024-02-06. Estimated completion is 2026-05-03.
What conditions does trial NCT05711615 study?
This clinical trial studies the following conditions: Metastatic Sarcoma, Metastatic Dedifferentiated Liposarcoma, Metastatic Leiomyosarcoma, Unresectable Dedifferentiated Liposarcoma, Unresectable Leiomyosarcoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05711615?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Biopsy Procedure (PROCEDURE), Echocardiography Test (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05711615?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05711615 being conducted?
This trial has 16 study locations across California, Colorado, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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