A Phase 2/3 Study of Olaparib and Temozolomide Versus the Usual Treatment of Trabectedin or Pazopanib for Metastatic Uterine Leiomyosarcoma


Full 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 (A092104) (CIRB)


This study is comparing the effect of the combination of olaparib and temozolomide to the usual treatment (trabectedin or pazopanib) for uterine leiomyosarcoma that has spread to other places in the body after initial chemotherapy has stopped working.

Olaparib works by inhibiting PARP, a protein that helps repair damaged DNA. Blocking PARP may prevent tumor cells from repairing their damaged DNA, causing them to die. Temozolomide works by slowing or stopping the growth of tumor cells. The combination of olaparib and temozolomide may work better than the usual treatment to shrink or stabilize advanced uterine leiomyosarcoma after initial chemotherapy has stopped working.

Participants in this study will be randomly assigned to receive one of these treatments:

  • Olaparib and temozolomide, which are both taken orally (by mouth).
  • Trabectedin (given by vein) OR pazopanib (taken orally)

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have inoperable or metastatic uterine leiomyosarcoma that continues to grow despite initial chemotherapy. They must have already received treatment with an anthracycline for uterine leiomyosarcoma.
  • Patients may not have received prior treatment with a PARP inhibitor, temozolomide, or dacarbazine.
  • At least 4 weeks must pass between the completion of prior therapies (including previous radiation treatment) and receipt of the study treatment.
  • Participants must have good heart, liver, kidney, lung, gastrointestinal, and blood function.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for women age 18 and older.


For more information about this study and to ask about eligibility, please contact the office of Dr. Martee Hensley at 646-888-4222.




Phase II/III (phases 2 and 3 combined)



ClinicalTrials.gov ID