Sponsor: Alliance for Clinical Trials in Oncology
Sponsor Study ID: A092104
Study Title: 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
CTO #: 103817
NCT Number: NCT05432791
Phase: II/III
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Corpus Uteri
Study Objectives: To compare the progression free survival (PFS) of olaparib plus temozolomide (Arm 1) as compared to investigator s choice (trabectedin or pazopanib) (Arm 2) for the treatment of patients with advanced uLMS who have received two or more prior lines of therapy as determined by investigator (local site) assessment. To compare 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 uLMS who have received two or more prior lines of therapy.