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
Polaris Group
Summary
To compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline.
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
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
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 systemi…
Interventions
- DrugADI PEG20
Treatment for advanced or metastatic uterine/non-uterine leiomyosarcoma (LMS)
- OtherPlacebo
Treatment for advanced or metastatic uterine/non-uterine leiomyosarcoma (LMS)
Locations (31)
- Mayo Clinic ArizonaPhoenix, Arizona
- USC Norris comprehensive cancer centerLos Angeles, California
- Stanford University Medical CentrePalo Alto, California
- UCSFSan Francisco, California
- UCLASanta Monica, California
- University of Colorado Cancer Center/ CU Anschutz Medical CampusAurora, Colorado