RECRUITING

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

Talk to us

Conditions

Soft Tissue SarcomaArginineArginine DeiminaseADI-PEG 20PegargiminaseLeiomyosarcoma

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2023-11-29
Study Completion:2027-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05712694

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.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * A subject will be eligible for study participation if he/she meets the following criteria:
  2. 1. Histologically or cytologically confirmed, grade 2 or 3, LMS STS that would be standardly treated with Gem or GemDoc.
  3. 2. Determination of LMS subtype: uterine or non-uterine.
  4. 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.
  5. 4. Previous treatment with up to 2 systemic regimens, including at least 1 systemic regimen containing doxorubicin.
  6. 5. Treatment \> one year ago in the adjuvant/neoadjuvant setting with Gem or Doc is allowed.
  7. 6. Age \>18 years.
  8. 7. Eastern Cooperative Oncology Group (ECOG) performance status of \< 1 at enrollment (Appendix B).
  9. 8. Leukocytes ≥ 3,000/mcL.
  10. 9. Absolute neutrophil count ≥ 1,500/mcL.
  11. 10. Platelets ≥ 100,000/mcL.
  12. 11. Total bilirubin ≤ 2 x ULN. (≤ 3 x ULN for potential subjects with Gilbert's Disease)
  13. 12. AST(SGOT)/ALT(SGPT) ≤ 3 x ULN (or ≤ 5 x ULN if liver metastases are present)
  14. 13. Creatinine clearance ≥ 60 mL/min (by Cockcroft-Gault equation).
  15. 14. Serum uric acid ≤ 8 mg/dL (with or without medication control).
  16. 15. QTc interval range from 350 to 450 ms for adult men and from 360 to 460 ms for adult women.
  17. 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.
  18. 17. Ability to understand and willingness to sign the informed consent form.
  19. 18. No concurrent investigational drug studies are allowed.
  1. * A subject will not be eligible for study participation if he/she meets any of the

Contacts and Locations

Study Contact

Mirla Langlois
CONTACT
858-452-6688
mlanglois@polarispharma.com
Stephanie V Rumund
CONTACT
858-452-6688
svanrumund@polarispharma.com

Principal Investigator

John S Bomalaski
STUDY_DIRECTOR
Polaris Group

Study Locations (Sites)

University of Colorado Cancer Center/ CU Anschutz Medical Campus
Aurora, Colorado, 80045
United States
University of Miami/ Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Northwestern
Chicago, Illinois, 60611
United States
Indiana University
Indianapolis, Indiana, 46202
United States
University of Iowa
Iowa City, Iowa, 52242
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Washington University School of Medicine - Siteman Cancer Center
Saint Louis, Missouri, 63110
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Duke Cancer Institute
Durham, North Carolina, 27710
United States
Wake Forest Baptist (Atrium Health)
Salem, North Carolina, 27157
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Ohio State University Wexner Medical Center/ The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, 43210
United States
UPenn (Abramson Cancer Center, Pennsylvania Hospital)
Philadelphia, Pennsylvania, 19106
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
Medical College of Wisconsin/ Froedtert Hospital
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Polaris Group

  • John S Bomalaski, STUDY_DIRECTOR, Polaris Group

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-29
Study Completion Date2027-12-30

Study Record Updates

Study Start Date2023-11-29
Study Completion Date2027-12-30

Terms related to this study

Keywords Provided by Researchers

  • Soft Tissue Sarcoma
  • Arginine
  • Arginine Deiminase
  • ADI-PEG 20
  • Pegargiminase
  • Leiomyosarcoma

Additional Relevant MeSH Terms

  • Soft Tissue Sarcoma