Actively Recruiting
Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
30
Participants Needed
16
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed metastatic or unresectable sarcoma with no known curative treatment
- Dose escalation cohort: diagnosis of leiomyosarcoma or selected soft tissue sarcomas including myxofibrosarcoma, undifferentiated pleomorphic sarcoma, synovial sarcoma, or dedifferentiated liposarcoma
- Dose expansion cohort: diagnosis of leiomyosarcoma
- Evaluable disease amenable to biopsy (dose escalation cohort)
- Measurable disease per RECIST 1.1 and amenable to biopsy (dose expansion cohort)
- At least one prior line of therapy; prior anthracycline use allowed if cumulative dose does not exceed 360 mg/m^2
- Age 18 years or older
- ECOG performance status 0 to 2 (Karnofsky score ≥ 60%)
- Absolute neutrophil count ≥ 1,500/mcL
- Platelet count ≥ 100,000/mcL
- Total bilirubin ≤ 1.5 times institutional upper limit of normal
- AST and ALT ≤ 3 times institutional upper limit of normal
- Hemoglobin ≥ 8 g/dL
- Glomerular filtration rate ≥ 51 mL/min/1.73 m^2
- HIV-infected patients on effective therapy with undetectable viral load within 6 months
- Patients with controlled hepatitis B or C infection as specified
- Patients with treated brain metastases stable without steroid support
- Patients with prior or concurrent malignancy not interfering with study
- Cardiac function classification of 2B or better per New York Heart Association
- Female patients of childbearing potential must have negative pregnancy test and use contraception during and after study as specified
- Male patients of reproductive potential must use contraception during and after study
- Ability to understand and sign informed consent, or have legally authorized representative
You will not qualify if you...
- Unresolved toxicities from prior cancer therapy greater than grade 1 except alopecia
- Prior palliative radiotherapy within 14 days or definitive radiotherapy within 42 days before treatment
- Concurrent use of other investigational agents
- History of allergic reactions to peposertib or similar compounds
- Inability to discontinue certain medications affecting cytochrome P450 enzymes as specified
- Inability to discontinue proton-pump inhibitors before treatment
- Left ventricular ejection fraction below institutional normal limit
- Uncontrolled intercurrent illness
- Inability to swallow tablets whole
- New or progressive brain metastases or leptomeningeal disease
- Pregnancy or breastfeeding
- Prior treatment with DNA-protein kinase inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Los Angeles General Medical Center
Los Angeles, California, United States, 90033
Actively Recruiting
2
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
UCHealth University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
4
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
5
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Suspended
6
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States, 60451
Actively Recruiting
7
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States, 60462
Suspended
8
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
9
National Cancer Institute Developmental Therapeutics Clinic
Bethesda, Maryland, United States, 20892
Actively Recruiting
10
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
11
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Suspended
12
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
13
Siteman Cancer Center-South County
St Louis, Missouri, United States, 63129
Actively Recruiting
14
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
15
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
16
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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