Polaris Group
To compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline.
Soft Tissue Sarcoma
ADI PEG20
Placebo
Phase 3
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 : | November 29, 2023 |
Estimated Primary Completion Date : | December 30, 2027 |
Estimated Study Completion Date : | December 30, 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: ADIGemDoc ADI-PEG 20: 36 mg/m2 on Day -7 of Cycle 1, and Days 1, 8, and 15 of each 21-day cycle Gemcitabine: 600 mg/m2 on days 1 and 8 of each 21-day cycle Docetaxel: 60 mg/m2 on day 8 of each 21-day cycle |
Drug: ADI PEG20 |
Placebo Comparator: PBOGemDoc Placebo: matched PBO on Day -7 of Cycle 1, and Days 1, 8, and 15 of each 21-day cycle Gemcitabine: 900 mg/m2 on days 1 and 8 of each 21-day cycle Docetaxel: 75 mg/m2 on day 8 of each 21-day cycle |
Other: Placebo |
Ages Eligible for Study: | 18 Years to 99 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Washington University School of Medicine - Siteman Cancer Center
Saint Louis, missouri, United States, 63110