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NCT05712694 | RECRUITING | Soft Tissue Sarcoma

Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC)
Sponsor:

Polaris Group

Brief Summary:

To compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline.

Condition or disease

Soft Tissue Sarcoma

Intervention/treatment

ADI PEG20

Placebo

Phase

PHASE3

Detailed Description:

This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 trial that will compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline.

Study Type : INTERVENTIONAL
Estimated Enrollment : 300 participants
Masking : TRIPLE
Masking Description : This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 trial
Primary Purpose : TREATMENT
Official Title : ADI-PEG 20 or Placebo Plus Gemcitabine and Docetaxel in Previously Treated Subjects With Leiomyosarcoma (ARGSARC): A Randomized, Double Blind, Multi-Center Phase 3 Trial
Actual Study Start Date : 2023-11-29
Estimated Primary Completion Date : 2027-12-30
Estimated Study Completion Date : 2027-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * A subject will be eligible for study participation if he/she meets the following criteria
    • 1. Histologically or cytologically confirmed, grade 2 or 3, LMS STS that would be standardly treated with Gem or GemDoc.
    • 2. Determination of LMS subtype: uterine or non-uterine.
    • 3. Measurable disease per RECIST 1.1 (Appendix A), defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam.
    • 4. Previous treatment with up to 2 systemic regimens, including at least 1 systemic regimen containing doxorubicin.
    • 5. Treatment \> one year ago in the adjuvant/neoadjuvant setting with Gem or Doc is allowed.
    • 6. Age \>18 years.
    • 7. Eastern Cooperative Oncology Group (ECOG) performance status of \< 1 at enrollment (Appendix B).
    • 8. Leukocytes ≥ 3,000/mcL.
    • 9. Absolute neutrophil count ≥ 1,500/mcL.
    • 10. Platelets ≥ 100,000/mcL.
    • 11. Hemoglobin ≥ 8.0 g/dL
    • 12. Total bilirubin ≤ 2 x ULN. (≤ 3 x ULN for potential subjects with Gilbert's Disease)
    • 13. AST(SGOT)/ALT(SGPT) ≤ 3 x ULN (or ≤ 5 x ULN if liver metastases are present)
    • 14. Creatinine clearance ≥ 60 mL/min (by Cockcroft-Gault equation).
    • 15. Serum uric acid ≤ 8 mg/dL (with or without medication control).
    • 16. QTc interval range from 350 to 450 ms for adult men and from 360 to 460 ms for adult women.
    • 17. Subjects and their partners must be asked to use appropriate contraception. They must agree to use 2 forms of contraception or agree to refrain from intercourse for the duration of the study and for 35 days after the last dose of ADI-PEG 20 or for at least 3 months (male subjects) or 6 months (female subjects) after treatment with gemcitabine, whichever is the longer duration.
    • 18. Ability to understand and willingness to sign the informed consent form.
    • 19. No concurrent investigational drug studies are allowed.
    Exclusion Criteria
    • * A subject will not be eligible for study participation if he/she meets any of the exclusion criteria
      • 1. Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the Investigator will not affect subject outcome in the setting of current diagnosis.
      • 2. Currently receiving chemotherapy, immunotherapy, interferon, radiation therapy or other investigational agents. Note: Chemotherapy agent washout period is 5 half-lives prior to randomization. Radiation washout period is 7 days prior to randomization.
      • 3. Prior treatment with ADI-PEG 20, Gem or Doc. Patients treated \> one year ago in the adjuvant/neoadjuvant setting with Gem or Doc are allowed to be enrolled.
      • 4. Prior pelvic radiation.
      • 5. Known brain metastases. Such patients must be excluded from this trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
      • 6. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ADI-PEG 20, Gem, Doc, polysorbate 80, pegylated compounds, or other agents used in this study.
      • 7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
      • 8. History of seizure disorder not related to underlying cancer.
      • 9. Grade 2 or higher neuropathy.
      • 10. Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
      • 11. Known HIV-positivity. Because of the potential for pharmacokinetic interactions of antiretroviral therapy with the study treatment. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
      • 12. Currently receiving other immunosuppressive agents.
      • 13. Subjects under guardianship, curatorship, under legal protection or deprived of liberty by an administrative or judicial decision
Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC)

Location Details

NCT05712694

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Mayo Clinic Arizona

Phoenix, Arizona, United States, 85054

RECRUITING

United States, California

USC Norris comprehensive cancer center

Los Angeles, California, United States, 90033

RECRUITING

United States, California

UCSF

San Francisco, California, United States, 94158

RECRUITING

United States, California

UCLA

Santa Monica, California, United States, 90404

RECRUITING

United States, Colorado

University of Colorado Cancer Center/ CU Anschutz Medical Campus

Aurora, Colorado, United States, 80045

RECRUITING

United States, Florida

Mayo Clinic Florida

Jacksonville, Florida, United States, 32224

RECRUITING

United States, Florida

University of Miami/ Sylvester Comprehensive Cancer Center

Miami, Florida, United States, 33136

RECRUITING

United States, Florida

Moffitt Cancer Center

Tampa, Florida, United States, 33612

RECRUITING

United States, Illinois

Northwestern

Chicago, Illinois, United States, 60611

RECRUITING

United States, Indiana

Indiana University

Indianapolis, Indiana, United States, 46202

RECRUITING

United States, Iowa

University of Iowa

Iowa City, Iowa, United States, 52242

NOT YET RECRUITING

United States, Massachusetts

Mass General Brigham Cancer Center

Boston, Massachusetts, United States, 02114

RECRUITING

United States, Road cancer

University of Michigan

Ann Arbor, Road cancer, United States, 48109

RECRUITING

United States, Minnesota

Mayo Clinic Rochester

Rochester, Minnesota, United States, 55905

RECRUITING

United States, Missouri

Washington University School of Medicine - Siteman Cancer Center

Saint Louis, Missouri, United States, 63110

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

RECRUITING

United States, North Carolina

Duke Cancer Institute

Durham, North Carolina, United States, 27710

RECRUITING

United States, Ohio

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106

NOT YET RECRUITING

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

RECRUITING

United States, Ohio

Ohio State University Wexner Medical Center/ The James Cancer Hospital and Solove Research Institute

Columbus, Ohio, United States, 43210

RECRUITING

United States, Pennsylvania

UPenn (Abramson Cancer Center, Pennsylvania Hospital)

Philadelphia, Pennsylvania, United States, 19106

RECRUITING

United States, Pennsylvania

UPMC Hillman Cancer Center

Pittsburg, Pennsylvania, United States, 15232

RECRUITING

United States, Texas

University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

United States, Wisconsin

Medical College of Wisconsin/ Froedtert Hospital

Milwaukee, Wisconsin, United States, 53226

RECRUITING

Canada, Ontario

UHN - Princess Margaret Cancer Center (Ontario)

Toronto, Ontario, Canada, M5G 2M9

RECRUITING

Canada, Quebec

McGill University Health Centre (Quebec)

Montréal, Quebec, Canada, H4a 311

RECRUITING

Taiwan, Niaosong District

Chang Gung Medical Foundation Kaohsiung

City fast, Niaosong District, Taiwan, 83301

RECRUITING

Taiwan,

National Taiwan University Hospital

Taipei, Taiwan, 10002

RECRUITING

Taiwan,

Taipei Veterans General Hospital

Taipei, Taiwan, 11217