๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-30

A Phase II Clinical Trial Evaluating the Combination of Olaparib and Temozolomide for the Treatment of Advanced Uterine Leiomyosarcoma (NCT03880019)

A Phase II Study of the PARP Inhibitor Olaparib in Combination With the DNA Damaging Agent Temozolomide for the Treatment of Advanced Uterine Leiomyosarcoma

๐Ÿ”ต Active, Not Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: National Cancer Institute (NCI)

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

This phase II trial studies olaparib and temozolomide in treating patients with uterine leiomyosarcoma (LMS) that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), that has spread from where it first started to other places in the body (metastatic) or cannot be removed by surgery (unresectable). PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Chemotherapy drugs, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving olaparib and temozolomide may work better than giving either drug alone in treating patients with LMS.

Who can join: Review the eligibility criteria below.

Location: Mayo Clinic Hospital in Arizona โ€” Phoenix, Arizona

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (15 Sites)

  • Mayo Clinic Hospital in Arizona โ€” Phoenix, Arizona
  • Stanford Cancer Institute Palo Alto โ€” Palo Alto, California
  • UCHealth University of Colorado Hospital โ€” Aurora, Colorado
  • UF Health Cancer Institute - Gainesville โ€” Gainesville, Florida
  • Mayo Clinic in Florida โ€” Jacksonville, Florida
  • Massachusetts General Hospital Cancer Center โ€” Boston, Massachusetts
  • Dana-Farber Cancer Institute โ€” Boston, Massachusetts
  • Wayne State University/Karmanos Cancer Institute โ€” Detroit, Michigan
  • Weisberg Cancer Treatment Center โ€” Farmington Hills, Michigan
  • Mayo Clinic in Rochester โ€” Rochester, Minnesota
  • Washington University School of Medicine โ€” St Louis, Missouri
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center โ€” New York, New York
  • Ohio State University Comprehensive Cancer Center โ€” Columbus, Ohio
  • UPMC Hillman Cancer Center โ€” Pittsburgh, Pennsylvania
  • VCU Massey Comprehensive Cancer Center โ€” Richmond, Virginia

๐Ÿ“ž Contact the Study Coordinator

Phone: (800) 664-4580

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—