This phase II/III trial compares the effect of the combination of olaparib and temozolomide to the usual treatment (trabectedin and pazopanib) for uterine leiomyosarcoma that has spread to other places in the body (advanced) after initial chemotherapy has stopped working. Olaparib is a PARP inhibitor. PARP is a protein that helps repair damaged deoxyribonucleic acid (DNA). Blocking PARP may prevent tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Temozolomide is in a class of medications called alkylating agents. It works by slowing or stopping the growth of tumor cells in the body. The combination of olaparib and temozolomide may work better than the usual treatment in shrinking or stabilizing advanced uterine leiomyosarcoma after initial chemotherapy has stopped working.
2 Primary · 4 Secondary · Reporting Duration: Up to 5 years
70 Total Participants · 2 Treatment Groups
Primary Treatment: Arm 1 (olaparib, temozolomide) · No Placebo Group · Phase 2 & 3
Age 18+ · All Participants · 10 Total Inclusion CriteriaMark “Yes” if the following statements are true for you: