A Randomized Phase 2/3 Study of Olaparib Plus Temozolomide Versus Investigator's Choice for the Treatment of Patients with Advanced Uterine Leiomyosarcoma After Progression on Prior Chemotherapy
To compare the progression free survival (PFS) and the overall survival (OS)of olaparib plus temozolomide (Arm 1) as compared to investigator’s choice (trabectedin or pazopanib) (Arm 2) for the treatment of patients with advanced uterine leiomyosarcoma who have received two or more prior lines of therapy as determined by investigator (local site) assessment.
Diagnosisadvanced uterine leiomyosarcoma (uLMS)
18 years of age or older
Patients must have had prior progression on, or intolerance to, at least two prior lines of systemic therapy for advanced uLMS
ARM 1 Olaparib + Temozolomide
ARM 2 Investigator’s Choice: Trabectedin or Pazopanib
For more information, visit ClinicalTrials.gov