Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working

Complete 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
Trial Phase: II/III
Investigator: Michael Wagner

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.

Keywords:
  • Sarcoma
  • Leiomyosarcoma
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Adult
II/III
Michael Wagner
RG1123390
NCT05633381
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
Sarcoma
Leiomyosarcoma