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

Description

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

Conditions

Soft Tissue Sarcoma

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Soft Tissue Sarcoma
Intervention / Treatment

-

Contacts and Locations

Aurora

University of Colorado Cancer Center/ CU Anschutz Medical Campus, Aurora, Colorado, United States, 80045

Miami

University of Miami/ Sylvester Comprehensive Cancer Center, Miami, Florida, United States, 33136

Tampa

Moffitt Cancer Center, Tampa, Florida, United States, 33612

Chicago

Northwestern, Chicago, Illinois, United States, 60611

Indianapolis

Indiana University, Indianapolis, Indiana, United States, 46202

Iowa City

University of Iowa, Iowa City, Iowa, United States, 52242

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Saint Louis

Washington University School of Medicine - Siteman Cancer Center, Saint Louis, Missouri, United States, 63110

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Durham

Duke Cancer Institute, Durham, North Carolina, United States, 27710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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. Total bilirubin ≤ 2 x ULN. (≤ 3 x ULN for potential subjects with Gilbert's Disease)
  • 12. AST(SGOT)/ALT(SGPT) ≤ 3 x ULN (or ≤ 5 x ULN if liver metastases are present)
  • 13. Creatinine clearance ≥ 60 mL/min (by Cockcroft-Gault equation).
  • 14. Serum uric acid ≤ 8 mg/dL (with or without medication control).
  • 15. QTc interval range from 350 to 450 ms for adult men and from 360 to 460 ms for adult women.
  • 16. 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.
  • 17. Ability to understand and willingness to sign the informed consent form.
  • 18. No concurrent investigational drug studies are allowed.
  • * A subject will not be eligible for study participation if he/she meets any of the

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Polaris Group,

John S Bomalaski, STUDY_DIRECTOR, Polaris Group

Study Record Dates

2027-12-30