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NCT05711615 · ClinicalTrials.gov registry record · Phase 1

Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma

A Phase 1 study of Metastatic Sarcoma and Metastatic Dedifferentiated Liposarcoma, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 1
Development phase
30
Enrollment target
16
Study locations

NCT05711615 is a Phase 1 study of Metastatic Sarcoma and Metastatic Dedifferentiated Liposarcoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 30 participants, below the 40-participant average among 12 other Metastatic Sarcoma trials with a reported enrollment target (25% lower). The trial reports 16 study locations across 11 states.

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The verdict

NCT05711615, a Phase 1 study of Metastatic Sarcoma and Metastatic Dedifferentiated Liposarcoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 1
Development phase
30 participants
Enrollment target
16
Study locations

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

Metastatic Sarcoma Metastatic Dedifferentiated Liposarcoma Metastatic Leiomyosarcoma Unresectable Dedifferentiated Liposarcoma Unresectable Leiomyosarcoma Metastatic Undifferentiated Pleomorphic Sarcoma Unresectable Sarcoma Metastatic Myxofibrosarcoma Metastatic Synovial Sarcoma Unresectable Myxofibrosarcoma

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

FieldValue
Enrollment Target 30 participants
Start Date 2024-02-06
Est. Completion 2026-05-03
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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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, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 40-participant average among 12 other Metastatic Sarcoma trials with a reported enrollment target (25% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

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.

NCT05711615 reports 16 study locations spanning 11 distinct geographic areas - top geographies include Illinois, California, Maryland.

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.

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).

Who is sponsoring clinical trial NCT05711615?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.