Polaris Group
To compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline.
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.
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…
Treatment for advanced or metastatic uterine/non-uterine leiomyosarcoma (LMS)
Treatment for advanced or metastatic uterine/non-uterine leiomyosarcoma (LMS)