Spots Global Cancer Trial Database for Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC)
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Trial Identification
Brief Title: Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC)
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
Study ID: NCT05712694
Conditions
Study Description
Brief Summary: To compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline.
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Colorado Cancer Center/ CU Anschutz Medical Campus, Aurora, Colorado, United States
University of Miami/ Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Northwestern, Chicago, Illinois, United States
Indiana University, Indianapolis, Indiana, United States
University of Iowa, Iowa City, Iowa, United States
University of Michigan, Ann Arbor, Michigan, United States
Washington University School of Medicine - Siteman Cancer Center, Saint Louis, Missouri, United States
Duke Cancer Institute, Durham, North Carolina, United States
Wake Forest Baptist (Atrium Health), Salem, North Carolina, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Ohio State University Wexner Medical Center/ The James Cancer Hospital and Solove Research Institute, Columbus, Ohio, United States
UPenn (Abramson Cancer Center, Pennsylvania Hospital), Philadelphia, Pennsylvania, United States
UHN - Princess Margaret Cancer Center (Ontario), Toronto, Ontario, Canada
McGill University Health Centre (Quebec), Montréal, Quebec, Canada
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Contact Details
Name: John S Bomalaski
Affiliation: Polaris Group
Role: STUDY_DIRECTOR
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