Actively Recruiting
Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC)
Led by Polaris Group · Updated on 2026-04-20
300
Participants Needed
31
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline.
CONDITIONS
Official Title
Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed grade 2 or 3 leiomyosarcoma (LMS) soft tissue sarcoma suitable for treatment with gemcitabine or gemcitabine plus docetaxel.
- Determined LMS subtype as uterine or non-uterine.
- Measurable disease per RECIST 1.1 criteria with lesions of specified size by CT scan, chest x-ray, or clinical exam.
- Previous treatment with up to 2 systemic regimens including at least one containing doxorubicin.
- Prior adjuvant/neoadjuvant treatment with gemcitabine or docetaxel allowed if more than one year ago.
- Age over 18 years.
- ECOG performance status less than 1 at enrollment.
- Leukocyte count of at least 3,000/mcL.
- Absolute neutrophil count of at least 1,500/mcL.
- Platelet count of at least 100,000/mcL.
- Hemoglobin level of at least 8.0 g/dL.
- Total bilirubin less than or equal to twice the upper limit of normal (or up to 3 times for Gilbert's disease).
- AST/ALT levels less than or equal to 3 times the upper limit of normal (or up to 5 times if liver metastases present).
- Creatinine clearance of at least 60 mL/min.
- Serum uric acid less than or equal to 8 mg/dL, with or without medication.
- QTc interval between 350 and 450 ms for men, 360 and 460 ms for women.
- Agreement to use appropriate contraception or abstain from intercourse during the study and for specified times after treatment.
- Ability to understand and sign informed consent.
- No concurrent participation in other investigational drug studies.
You will not qualify if you...
- History of another primary cancer except curatively treated non-melanoma skin cancer, cervical carcinoma in situ, or other solid tumors with no active disease.
- Currently receiving chemotherapy, immunotherapy, interferon, radiation, or other investigational agents; with specified washout periods before randomization.
- Prior treatment with ADI-PEG 20, gemcitabine, or docetaxel except if given over one year ago in adjuvant/neoadjuvant setting.
- Prior pelvic radiation.
- Known brain metastases.
- History of allergic reactions to ADI-PEG 20, gemcitabine, docetaxel, or related compounds.
- Uncontrolled illnesses including infection, heart failure, unstable angina, arrhythmia, psychiatric illness, or social situations limiting compliance.
- History of seizure disorder not related to cancer.
- Grade 2 or higher neuropathy.
- Pregnant or breastfeeding; women of childbearing potential must have a negative pregnancy test within 14 days before entry.
- Known HIV positivity.
- Currently receiving other immunosuppressive agents.
- Subjects under legal guardianship, curatorship, legal protection, or deprived of liberty by judicial decision.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
USC Norris comprehensive cancer center
Los Angeles, California, United States, 90033
Actively Recruiting
3
Stanford University Medical Centre
Palo Alto, California, United States, 94304
Actively Recruiting
4
UCSF
San Francisco, California, United States, 94158
Actively Recruiting
5
UCLA
Santa Monica, California, United States, 90404
Actively Recruiting
6
University of Colorado Cancer Center/ CU Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
7
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
8
University of Miami/ Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
9
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
10
Northwestern
Chicago, Illinois, United States, 60611
Actively Recruiting
11
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
12
University of Iowa
Iowa City, Iowa, United States, 52242
Active, Not Recruiting
13
Mass General Brigham Cancer Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
14
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
15
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
16
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States, 63110
Actively Recruiting
17
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
18
Columbia University
New York, New York, United States, 10032
Not Yet Recruiting
19
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
20
Duke Cancer Institute
Durham, North Carolina, United States, 27710
Actively Recruiting
21
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
22
Ohio State University Wexner Medical Center/ The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States, 43210
Actively Recruiting
23
UPenn (Abramson Cancer Center, Pennsylvania Hospital)
Philadelphia, Pennsylvania, United States, 19106
Actively Recruiting
24
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
25
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
26
Medical College of Wisconsin/ Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
27
UHN - Princess Margaret Cancer Center (Ontario)
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
28
McGill University Health Centre (Quebec)
Montreal, Quebec, Canada, H4A 311
Actively Recruiting
29
Chang Gung Medical Foundation Kaohsiung
Kaohsiung City, Niaosong District, Taiwan, 83301
Actively Recruiting
30
National Taiwan University Hospital
Taipei, Taipei, Taiwan, 10002
Actively Recruiting
31
Taipei Veterans General Hospital
Taipei, Taipei, Taiwan, 11217
Actively Recruiting
Research Team
M
Mirla Langlois
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here